82 FR 13609 - Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 48 (March 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 48 (March 14, 2017)
| Page Range | 13609-13632 | |
| FR Document | 2017-04938 |
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)] [Notices] [Pages 13609-13632] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04938] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1129] Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st [[Page 13610]] Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register. DATES: Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-1129 for ``Medical Devices; Exemptions from Premarket Notification: Class II Devices.'' Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) [[Page 13611]] containing information that allows FDA to determine whether the new device is ``substantially equivalent'' within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. On December 13, 2016, the President signed into law the 21st Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires FDA to publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA is required to publish this notice within 90 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the exemption of the devices that were contained in the present list published under section 510(m)(1)(A) of the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. In a final action, and after considering comments, FDA intends to amend the codified language for each listed regulation to reflect the final determination with respect to exempt devices. FDA's final action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in 510(k) notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review. II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff'' (Ref. 1). III. Limitations on Exemptions FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's initial determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide. In addition to being subject to the general limitations to the exemptions found in Sec. Sec. 862.9 to 892.9) 21 CFR 862.9 to 892.9, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA is listing the exemption of the endoscopic magnetic retriever, but limits the exemption to such devices that are for single use. All other endoscopic magnetic retrievers are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. IV. List of Class II Devices FDA is identifying the following list of class II devices that, if finalized, would no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in Sec. Sec. 862.9 to 892.9: Table 1--Class II Devices ------------------------------------------------------------------------ Partial exemption 21 CFR section Device type Product limitation (if code applicable) ------------------------------------------------------------------------ 862.1020............. Acid CJN .................... Phosphatase, Nitrophenylpho sphate. 862.1020............. Acid CJR .................... Phosphatase, Thymol Blue Monophosphate. 862.1020............. Acid CJX .................... Phosphatase, Disodium Phenylphosphat e. 862.1020............. Acid CKB .................... Phosphatase, Naphthyl Phosphate. 862.1020............. Acid CKE .................... Phosphatase, Thymolphthale Inmonophosphat e. 862.1020............. Acid CKH .................... Phosphatase, Beta Glycerophospha te. 862.1020............. Acid JFH .................... Phosphatase (Prostatic), Tartrate Inhibited. 862.1090............. Radioassay, KQN .................... Angiotensin Converting Enzyme. 862.1100............. Vanillin CIF .................... Pyruvate, AST/ SGOT. 862.1100............. Diazo, AST/SGOT CIQ .................... 862.1100............. Hydrazone CIS .................... Colorimetry, AST/SGOT. 862.1100............. NADH Oxidation/ CIT .................... NAD Reduction, AST/SGOT. 862.1150............. Calibrator, JIS .................... Primary. 862.1150............. Calibrator, JIT .................... Secondary. [[Page 13612]] 862.1150............. Calibrator, JIW .................... Surrogate. 862.1150............. Calibrator, JIX .................... Multi-Analyte Mixture. 862.1345............. Drink, Glucose MRV .................... Tolerance. 862.1350............. Continuous PJT .................... Glucose Monitor Secondary Display. 862.1445............. Chromatographic CEX .................... Separation, Lactate Dehydrogenase Isoenzymes. 862.1445............. Electrophoretic CFE .................... , Lactate Dehydrogenase Isoenzymes. 862.1445............. Differential JGF .................... Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes. 862.1509............. System, Test, LPT .................... Urinary Methylmalonic Acid. 862.1685............. Radioimmunoassa CEE .................... y, Thyroxine- Binding Globulin. 862.1700............. Radioimmunoassa CDX .................... y, Total Thyroxine. 862.1700............. Enzyme KLI .................... Immunoassay, Non- Radiolabeled, Total Thyroxine. 862.2265............. High Throughput PFF .................... DNA Sequence Analyzer. 862.2570............. Instrumentation NSU .................... For Clinical Multiplex Test Systems. 862.2570............. Real Time OOI .................... Nucleic Acid Amplification System. 862.2570............. Mass OTA .................... Spectrometer For Clinical Multiplex Test Systems. 862.2570............. Micro Total OUE .................... Analysis Instrument System. 862.2570............. Complete Gene OVA .................... Expression Profiling Accessory Reagents. 862.2570............. DNA Genetic PCA .................... Analyzer. 862.2570............. Data PQQ .................... Acquisition Software. 862.3100............. Enzyme DKZ Exemption is limited Immunoassay, to test systems Amphetamine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100............. Radioimmunoassa DJP Exemption is limited y, Amphetamine. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100............. Thin Layer DIT Exemption is limited Chromatography to test systems , Amphetamine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100............. Gas DOD Exemption is limited Chromatography to test systems , Amphetamine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3100............. Liquid DNI Exemption is limited Chromatography to test systems , Amphetamine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. Enzyme DJL Exemption is limited Immunoassay, to test systems Barbiturate. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. Enzyme DIS Exemption is limited Immunoassay, to test systems Barbiturate. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). [[Page 13613]] 862.3150............. Radioimmunoassa DKN Exemption is limited y, Barbiturate. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. Thin Layer DKX Exemption is limited Chromatography to test systems , Barbiturate. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. Mercury DJN Exemption is limited Dithiazone, to test systems Colorimetry, intended for Barbiturate. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. Hemagglutinatio DLX Exemption is limited n Inhibition, to test systems Barbiturate. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. Gas Liquid DMF Exemption is limited Chromatography to test systems , Barbiturate. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3150............. High Pressure KZY Exemption is limited Liquid to test systems Chromatography intended for , Barbiturate. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170............. Enzyme JXM Exemption is limited Immunoassay, to test systems Benzodiazepine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170............. High Pressure LAA Exemption is limited Liquid to test systems Chromatography intended for , employment and Benzodiazepine. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170............. Test, NFV Exemption is limited Benzodiazepine to test systems , Over The intended for Counter. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170............. Gas KZZ Exemption is limited Chromatography to test systems , intended for Benzodiazepine. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3170............. Thin Layer LAB Exemption is limited Chromatography to test systems , intended for Benzodiazepine. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3200............. Calibrators, DKB .................... Drug Mixture. 862.3200............. Calibrators, DLJ .................... Drug Specific. 862.3200............. Calibrators, DNN .................... Ethyl Alcohol. 862.3250............. Enzyme DIO Exemption is limited Immunoassay, to test systems Cocaine and intended for Cocaine employment and Metabolites. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. Radioimmunoassa KLN Exemption is limited y, Cocaine to test systems Metabolite. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). [[Page 13614]] 862.3250............. Enzyme JXO Exemption is limited Immunoassay, to test systems Cocaine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. Hemagglutinatio DLN Exemption is limited n, Cocaine to test systems Metabolites intended for (Benzoylecgoni employment and ne). insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. Thin Layer DMN Exemption is limited Chromatography to test systems , Cocaine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. Free Radical DIR Exemption is limited Assay, Cocaine. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. Gas DIN Exemption is limited Chromatography to test systems , Cocaine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. Thin Layer DOM Exemption is limited Chromatography to test systems , intended for Benzoylecgonin employment and e. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3250............. High Pressure LAC Exemption is limited Liquid to test systems Chromatography intended for , Cocaine and employment and Cocaine insurance testing Metabolites. and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3270............. High Pressure LAE Exemption is limited Liquid to test systems Chromatography intended for , Codeine. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3270............. Thin Layer DLD Exemption is limited Chromatography to test systems , Codeine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3270............. Gas LAD Exemption is limited Chromatography to test systems , Codeine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3580............. Radioimmunoassa DLB Exemption is limited y, LSD (125-I). to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3580............. Free Radical DOL Exemption is limited Assay, LSD. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610............. Gas LAF Exemption is limited Chromatography to test systems , intended for Methamphetamin employment and e. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610............. Thin Layer DJC Exemption is limited Chromatography to test systems , intended for Methamphetamin employment and e. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). [[Page 13615]] 862.3610............. High Pressure LAG Exemption is limited Liquid to test systems Chromatography intended for , employment and Methamphetamin insurance testing e. and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3610............. Test, NGG Exemption is limited Methamphetamin to test systems e, Over The intended for Counter. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620............. Enzyme DJR Exemption is limited Immunoassay, to test systems Methadone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620............. Hemagglutinatio DIW Exemption is limited n Inhibition, to test systems Methadone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620............. Gas DMB Exemption is limited Chromatography to test systems , Methadone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620............. Thin Layer DKR Exemption is limited Chromatography to test systems , Methadone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620............. Liquid DNT Exemption is limited Chromatography to test systems , Methadone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3620............. Free Radical DPP Exemption is limited Assay, to test systems Methadone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3630............. Radioimmunoassa KXS Exemption is limited y, to test systems Methaqualone. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Thin Layer DNK Exemption is limited Chromatography to test systems , Morphine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Radioimmunoassa DOE Exemption is limited y, Morphine to test systems (123-I), Goat intended for Antibody employment and Ammonium insurance testing Sulfate Sep.. and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Fluorometry, DJJ Exemption is limited Morphine. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Liquid DPK Exemption is limited Chromatography to test systems , Morphine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Gas DMY Exemption is limited Chromatography to test systems , Morphine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). [[Page 13616]] 862.3640............. Hemagglutinatio DLR Exemption is limited n Inhibition, to test systems Morphine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Free Radical DOK Exemption is limited Assay, to test systems Morphine. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Radioimmunoassa DIQ Exemption is limited y, Morphine (3- to test systems H), Goat intended for Antibody employment and Ammonium insurance testing Sulfate Sep.. and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3640............. Radioimmunoassa DNA Exemption is limited y, Morphine- to test systems Barbiturate intended for (125-I), Goat employment and Antibody. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650............. Enzyme DJG Exemption is limited Immunoassay, to test systems Opiates. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650............. Gas DJF Exemption is limited Chromatography to test systems , Opiates. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650............. Hemagglutinatio DLT Exemption is limited n, Opiates. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650............. Thin Layer LAI Exemption is limited Chromatography to test systems , Opiates. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650............. Free Radical DKT Exemption is limited Assay, Opiates. to test systems intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3650............. High Pressure LAH Exemption is limited Liquid to test systems Chromatography intended for , Opiates. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700............. Enzyme JXN Exemption is limited Immunoassay, to test systems Propoxyphene. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700............. Thin Layer DPN Exemption is limited Chromatography to test systems , Propoxyphene. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700............. Gas LAJ Exemption is limited Chromatography to test systems , Propoxyphene. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3700............. High Pressure LAK Exemption is limited Liquid to test systems Chromatography intended for , Propoxyphene. employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). [[Page 13617]] 862.3870............. Enzyme LDJ Exemption is limited Immunoassay, to test systems Cannabinoids. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3870............. Reagents, Test, DKE Exemption is limited Tetrahydrocann to test systems abinol. intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3870............. Radioimmunoassa LAT Exemption is limited y, to test systems Cannabinoid(S). intended for employment and insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3910............. High Pressure LFI Exemption is limited Liquid to test systems Chromatography intended for , Tricyclic employment and Antidepressant insurance testing Drugs. and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3910............. U.V. LFH Exemption is limited Spectrometry, to test systems Tricyclic intended for Antidepressant employment and Drugs. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 862.3910............. Thin Layer MLK Exemption is limited Chromatography to test systems , Tricyclic intended for Antidepressant employment and Drugs. insurance testing and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.). 864.5400............. Fibrometer..... GIE .................... 864.5400............. Timer, JBT .................... Coagulation. 864.5425............. Control, GGC .................... Plasma, Abnormal. 864.5425............. Plasma, GGN .................... Coagulation Control. 864.5425............. Plasma, GIZ .................... Control, Normal. 864.6550............. Control, Fecal OSL .................... Occult Blood. 864.6650............. Study, Platelet JBZ .................... Adhesive. 864.7275............. Test, JBO .................... Euglobulin Lysis. 864.7300............. Fibrin Monomer JBN .................... Paracoagulatio n. 864.7340............. Fibrinogen GFX .................... Standard. 864.7340............. Plasma, GIL .................... Fibrinogen Control. 864.7375............. Glutathione, GII .................... Red-Cell. 864.7375............. Fluorescence, JMH .................... Visual Observation (Qual., U.V.), Glutathione Reductase. 864.7375............. Assay, KQF .................... Glutathione Reductase. 864.7415............. Control, JCM .................... Hemoglobin, Abnormal. 864.7455............. Stain, Fetal GHQ .................... Hemoglobin. 864.7500............. Acid Hematin... GGF .................... 864.7720............. Test, GGQ .................... Prothrombin Consumption. 864.7735............. Prothrombin- JPF .................... Proconvertin and Thrombotest. 864.8150............. Calibrator for KRX .................... Cell Indices. 864.8165............. Calibrator for KRZ .................... Hemoglobin and Hematocrit Measurement. 864.8175............. Calibrator for KRY .................... Platelet Counting. 864.8185............. Calibrator for KSA .................... Red-Cell and White-Cell Counting. 864.8625............. Standards and GFS .................... Controls, Hemoglobin, Normal and Abnormal. 864.8625............. Control, White- GGL .................... Cell. 864.8625............. Control, GGM .................... Hemoglobin. 864.8625............. Control, GJP .................... Platelet. 864.8625............. Control, Red- GJR .................... Cell. 864.8625............. Control, GLK .................... Hematocrit. 864.8625............. Mixture, GLQ .................... Control, White- Cell and Red- Cell Indices. 864.8625............. Control, Cell JCN .................... Counter, Normal and Abnormal. 864.8625............. Mixture, JPK .................... Hematology Quality Control. [[Page 13618]] 864.8625............. Material, NRF .................... Quality Control, Semen Analysis. 864.8625............. Control NRS .................... Material, Blood Circulating Epithelial Cancer Cell. 864.9400............. Solution, KSK .................... Stabilized Enzyme. 866.3395............. Norovirus OUC .................... Serological Reagents. 866.5210............. Immunochemical, CHN .................... Ceruloplasmin. 866.5210............. Ceruloplasmin, DCT .................... Rhodamine, Antigen, Antiserum, Control. 866.5210............. Ceruloplasmin, DCY .................... FITC, Antigen, Antiserum, Control. 866.5210............. Ceruloplasmin, DDB .................... Antigen, Antiserum, Control. 866.5210............. P-Phenyl- JFQ .................... Enediamine/ EDTA (Spectrophotom etric), Ceruloplasmin. 866.5210............. Indirect Copper JFR .................... Assay, Ceruloplasmin. 866.5470............. Hemoglobin, DAM .................... Chain Specific, Antigen, Antiserum, Control. 866.5620............. Alpha-2- DDT .................... Macroglobulin, Rhodamine, Antigen, Antiserum, Control. 866.5620............. Alpha-2- DDY .................... Macroglobulin, FITC, Antigen, Antiserum, Control. 866.5620............. Alpha-2- DEB .................... Macroglobulin, Antigen, Antiserum, Control. 866.5630............. System, Test, JZG .................... Beta-2- Microglobulin Immunological. 866.5750............. System, Test, DHB Exemption is limited Radioallergoso to devices rbent (RAST) classified under 21 Immunological. CFR 866.5750 that are intended to detect any of the allergens included in table 2 of this document. 866.5910............. Quality Control NZB .................... Material, Genetics, DNA. 868.1040............. Algesimeter, BSI .................... Powered. 868.1400............. Legging, LLK .................... Compression, Non-Inflatable. 868.2385............. Analyzer, MRQ Exemption is limited Nitrogen to standalone Dioxide. nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy. 868.2500............. Monitor, KLK .................... Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia. 868.2500............. Monitor, LPP .................... Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia. 868.2550............. Pneumotachomete JAX .................... r. 868.5180............. Bed, Rocking, CCO .................... Breathing Assist. 868.6250............. Compressor, BTI .................... Air, Portable. 870.1330............. Wire, Guide, DQX Exemption is limited Catheter. to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non- cerebral vascular guide wires. 870.1390............. Trocar......... DRC .................... 870.1650............. Syringe, MAV Exemption is limited Balloon to non-patient Inflation. contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon. 870.1875............. Lung Sound OCR .................... Monitor. 870.2675............. Oscillometer... DRZ .................... 870.2770............. Analyzer, Body MNW Exemption is limited Composition. to body composition analyzers which are not intended to diagnose or treat any medical condition. 870.4280............. Filter, KRJ .................... Prebypass, Cardiopulmonar y Bypass. 870.4290............. Adaptor, DTL .................... Stopcock, Manifold, Fitting, Cardiopulmonar y Bypass. 870.4340............. Monitor and/or DTW .................... Control, Level Sensing, Cardiopulmonar y Bypass. 870.4400............. Reservoir, DTN Exemption is limited Blood, to cardiopulmonary Cardiopulmonar bypass blood y Bypass. reservoirs that do not contain defoamers or blood filters. 870.4420............. Sucker, DTS .................... Cardiotomy Return, Cardiopulmonar y Bypass. 870.4430............. Suction DWD .................... Control, Intracardiac, Cardiopulmonar y Bypass. 872.1720............. Tester, Pulp... EAT .................... [[Page 13619]] 872.3260............. External PME .................... Cleaning Solution. 872.3300............. Coating, EBE .................... Denture Hydrophilic, Resin. 872.3540............. Pad, Denture, EHR .................... Over The Counter. 872.3540............. Cushion, EHS .................... Denture, Over The Counter. 872.3560............. Reliner, EBP .................... Denture, Over The Counter. 872.3590............. Denture, ELM .................... Plastic, Tooth. 872.3600............. Denture EKO .................... Preformed (Partially Prefabricated Denture). 872.3890............. Splint, ELS .................... Endodontic Stabilizing. 872.5550............. Ring, Teething, KKO .................... Fluid-Filled. 872.6770............. Syringe, EJI .................... Cartridge. 874.1090............. Tester, ETY Exemption is limited Auditory to auditory Impedance. impedance testers that are in compliance with FDA- recognized consensus standard ANSI S3.39. 874.1090............. Tympanometer... NAS Exemption is limited to tympanometers that are in compliance with FDA- recognized consensus standard ANSI S3.39. 874.1120............. Generator, ETS .................... Electronic Noise (for Audiometric Testing). 874.1325............. Electroglottogr KLX .................... aph. 874.3310............. Calibrator, ETW .................... Hearing Aid/ Earphone and Analysis Systems. 874.3320............. Hearing Aid, EPF .................... Group and Auditory Trainer. 874.3320............. Device, LZI .................... Assistive Listening. 874.3330............. Hearing Aid, KHL .................... Master. 874.3430............. Mold, Middle- ETC .................... Ear. 874.3730............. Device, Voice MCK .................... Amplification. 876.1500............. Endoscopic FCC Exemption is limited Magnetic to endoscopic Retriever. magnetic retrievers intended for single use. 876.1500............. Light Source, FCQ .................... Incandescent, Diagnostic. 876.1500............. Light Source, FCR .................... Photographic, Fiberoptic. 876.1500............. Light Source, FCW .................... Fiberoptic, Routine. 876.1500............. Carrier, FGS .................... Sponge, Endoscopic. 876.1500............. Light Source, GCT .................... Endoscope, Xenon Arc. 876.1500............. Transformer, GCW .................... Endoscope. 876.1500............. Scissors For KGD Exemption is limited Cystoscope. to sterile scissors for cystoscope intended for single use. 876.1500............. LED Light NTN .................... Source. 876.1500............. Endoscopic OCY .................... Guide Wire, Gastroenterolo gy-Urology. 876.1500............. Endoscopic OCZ Exemption is limited Grasping/ to disposable, non- Cutting powered endoscopic Instrument, grasping/cutting Non-Powered. instruments intended for single use. 876.4020............. Light, FCS .................... Catheter, Fiberoptic, Glass, Ureteral. 876.4270............. Rod, Colostomy. EZP .................... 876.4400............. Ligator, FHN .................... Hemorrhoidal. 876.4400............. Ligator, MND .................... Esophageal. 876.4500............. Lithotriptor, LQC .................... Biliary Mechanical. 876.4770............. Urethrotome.... EZO .................... 876.5010............. Bag, Bile EXF .................... Collecting. 876.5010............. Catheter, GCA Exemption is limited Biliary, to surgical biliary Surgical. catheters that do not include a balloon component. 876.5025............. Vibrator for PIA .................... Climax Control of Premature Ejaculation. 876.5365............. Dilator, EZM .................... Esophageal (Metal Olive) Gastro-Urology. 876.5365............. Bougie, FAT .................... Esophageal, and Gastrointestin al, Gastro- Urology. 876.5365............. Dilator, KNQ .................... Esophageal. 876.5520............. Dilator, KOE .................... Urethral. 876.5630............. Catheter, FJS Exemption is limited Peritoneal, to non-patient Long-Term contacting catheter Indwelling. finger grips intended for single use. 876.5630............. Catheter, FKO Exemption is limited Peritoneal to non-patient Dialysis, contacting catheter Single Use. finger grips intended for single use. 876.5630............. System, FKX Exemption is limited Peritoneal, to continuous Automatic ambulatory Delivery. peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales. 876.5665............. Disinfectant, NIH .................... Subsystem, Water Purification. 876.5820............. Set, Dialyzer FKI .................... Holder. 876.5895............. Irrigator, EXD .................... Ostomy. [[Page 13620]] 876.5980............. Catheter, FGD .................... Retention, Barium Enema With Bag. 876.5980............. Gastrostomy PLI .................... Tube Holder. 878.4370............. Drape, ERY .................... Surgical, ENT. 878.4370............. Drape, Pure EYX .................... Latex Sheet, With Self- Retaining Finger Cot. 878.4370............. Drape, EYY .................... Urological, Disposable. 878.4370............. Pad, Kelly..... FNW .................... 878.4370............. Drape, Patient, HMT .................... Ophthalmic. 878.4370............. Drape, HMW .................... Microscope, Ophthalmic. 878.4370............. Ring (Wound KGW .................... Protector), Drape Retention, Internal. 878.4370............. Drape, Surgical KKX Exemption is limited to surgical drapes that do not include an antimicrobial agent. 878.4495............. Suture, GAQ Exemption is limited Nonabsorbable, to steel Steel, monofilament Monofilament sutures that are And uncoated and do not Multifilament, incorporate barbs. Sterile. 878.4580............. Lamp, Operating- FQP .................... Room. 878.4580............. Light, FSQ .................... Surgical, Instrument. 878.4580............. Light, FSS .................... Surgical, Floor Standing. 878.4580............. Light, FSW .................... Surgical, Endoscopic. 878.4580............. Light, FSX .................... Surgical, Connector. 878.4580............. Light, FSY .................... Surgical, Ceiling Mounted. 878.4580............. Light, FSZ .................... Surgical, Carrier. 878.4580............. Light, FTA .................... Surgical, Accessories. 878.4580............. Lamp, Surgical. FTD .................... 878.4580............. Illuminator, FTG .................... Remote. 878.4580............. Lamp, Surgical, GBC .................... Incandescent. 878.5070............. Apparatus, Air FZG .................... Handling, Bench. 878.5070............. Apparatus, Air FZH .................... Handling, Room. 878.5070............. Apparatus, Air FZI .................... Handling, Enclosure. 880.5580............. Locator, BWJ .................... Acupuncture Point. 880.5580............. Needle, MQX .................... Acupuncture, Single Use. 880.5780............. Stocking, DWL .................... Medical Support (to Prevent Pooling of Blood in Legs). 882.1020............. Analyzer, GZM .................... Rigidity. 882.1470............. Computerized PKQ Exemption is limited Cognitive to computerized Assessment Aid. cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/ or functional use of the hand. 882.1540............. Device, GZO .................... Galvanic Skin Response Measurement. 882.1560............. Device, Skin HCJ .................... Potential Measurement. 882.1855............. Encephalogram GYE .................... Telemetry System. 882.5895............. Vibratory OVP .................... Counter- Stimulation. 884.1630............. Colposcope (and HEX Exemption is limited Colpomicroscop to standard e). colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based. 884.2990............. Sheet, NHM .................... Recording, Breast Examination. 884.3200............. Drain, Cervical HFL .................... 884.4400............. Forceps, HDA .................... Obstetrical. 884.4530............. Tenaculum, HDC Exemption is limited Uterine. to sterile urterine tenaculum devices that do not use suction and are intended for single use. 884.4530............. Clamp, HFW .................... Umbilical. 884.4530............. Speculum, HIB .................... Vaginal, Nonmetal. 884.4530............. Speculum, HIC .................... Vaginal, Nonmetal, Fiberoptic. 884.4530............. Clamp and NBZ .................... Cutter, Umbilical. 884.4900............. Table, HDD .................... Obstetrical, AC-Powered (and Accessories). 884.4900............. Table, HHP .................... Obstetrical, Manual (and Accessories). 884.4900............. Table, KNC .................... Obstetric (and Accessories). 884.5200............. Hemorrhoid OOA .................... Prevention Pressure Wedge. 884.5390............. Heater, HGZ .................... Perineal, Direct Contact. 884.5390............. Heater, HHA .................... Perineal, Radiant, Non- Contact. 884.5390............. Heater, KND .................... Perineal. 884.5400............. Cup, Menstrual. HHE .................... [[Page 13621]] 884.5425............. Pad, Menstrual, HHL .................... Scented. 884.6120............. Accessory, MQG Exemption is limited Assisted to single embryo Reproduction. incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/ microscope stage warmers; and controlled-rate cryopreservation freezers. 884.6130............. Microtools, MQH Exemption is limited Assisted to assisted Reproduction reproduction (Pipettes). microtools (pipettes) manufactured from glass. 884.6150............. Micromanipulato MQJ .................... rs and Microinjectors , Assisted Reproduction. 884.6160............. Labware, MQK Exemption is limited Assisted to dishes and Reproduction. plates that are intended for general assisted reproduction technology procedures. 886.1120............. Photorefractor. MMF .................... 886.1120............. Camera, PJZ .................... Ophthalmic, General-Use. 886.1250............. Euthyscope, AC- HMK .................... Powered. 886.1570............. Ophthalmoscope, HLI .................... AC-Powered. 886.1570............. Ophthalmoscope, HLJ .................... Battery- Powered. 886.1570............. Ophthalmoscopes MSG .................... , Replacement Batteries, Hand-Held. 886.1780............. Retinoscope, AC- HKL .................... Powered. 886.1850............. Biomicroscope, HJO Exemption is limited Slit-Lamp, AC- to slit-lamp, AC- Powered. powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA- recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications. 886.1945............. Transilluminato HJM .................... r, AC-Powered. 886.3320............. Ocular Peg..... MQU Exemption is limited to ocular pegs supplied sterile. 886.4150............. Tubing, MSR .................... Replacement, Phacofragmenta tion Unit. 886.4250............. Unit, HRO .................... Electrolysis, AC-Powered, Ophthalmic. 886.4335............. Headlight, FCT .................... Fiberoptic Focusing. 886.4335............. Light, FSR .................... Headband, Surgical. 886.4335............. Headlamp, HPQ .................... Operating, AC- Powered. 886.4400............. Locator, Metal, HPM .................... Electronic. 886.4440............. Magnet, AC- HPO .................... Powered. 886.4790............. Sponge, HOZ .................... Ophthalmic. 886.4790............. Eye Tray....... OJK .................... 888.1240............. Dynamometer, AC- LBB .................... Powered. 888.4580............. Instrument, JDX .................... Surgical, Sonic and Accessory/ Attachment. 888.4580............. System, Cement LZV .................... Removal Extraction. 890.1450............. Hammer, Reflex, IKO .................... Powered. 890.5100............. Bath, Hydro- ILJ .................... Massage. 890.5100............. Bath, Sitz, ILM .................... Powered. 890.5110............. Bath, Paraffin. IMC .................... 890.5250............. Cabinet, Moist IMB .................... Steam. 890.5360............. Exerciser, ISD .................... Measuring. 890.5500............. Lamp, Infrared, ILY .................... Therapeutic Heating. 890.5575............. Device, IRN .................... Warning, Overload, External Limb, Powered. 892.1000............. MRI Disposable OIM .................... Kit. 892.1560............. Biopsy Needle OIJ .................... Guide Kit. 892.1610............. Aperature, IZS .................... Radiographic. 892.1610............. Cone, IZT .................... Radiographic. 892.1610............. Collimator, IZW .................... Automatic, Radiographic. 892.1610............. Collimator, IZX .................... Manual, Radiographic. 892.1610............. Device, Beam KPW .................... Limiting, X- Ray, Diagnostic. 892.1650............. Arthrogram Tray OII .................... 892.1650............. Radiology OIK .................... Dental Tray. 892.1670............. Device, Spot- IXL .................... Film. 892.1680............. Radiographic OIO .................... Contrast Tray. 892.1680............. Radiology OIP .................... Diagnostic Kit. 892.1730............. Discography Kit OIL .................... 892.1820............. Chair, HBK .................... Pneumocephalog raphic. 892.1850............. Cassette, IXA .................... Radiographic Film. 892.1860............. Changer, KPX .................... Radiographic Film/Cassette. 892.1870............. Programmer, IZP .................... Changer, Film/ Cassette, Radiographic. [[Page 13622]] 892.1900............. Controller, EGT .................... Temperature, Radiographic. 892.1900............. Dryer, Film, EGW .................... Radiographic. 892.1900............. Processor, EGY .................... Radiographic- Film, Automatic, Dental. 892.1900............. Processor, IXW .................... Radiographic- Film, Automatic. 892.1900............. Processor, Cine IXX .................... Film. 892.2030............. Digitizer, LMA .................... Image, Radiological. 892.2030............. Digitizer, NFH .................... Images, Ophthalmic. 892.2040............. Camera, Multi LMC .................... Format, Radiological. 892.2040............. Device, NFI .................... Hardcopy, Images, Ophthalmic. 892.5730............. Prostate OIN .................... Seeding Kit. ------------------------------------------------------------------------ In table 1, FDA included devices classified under Sec. 866.5750 (Radioallergosorbent (RAST) immunological test system, product code ``DHB''). FDA does not believe that all devices with the product code DHB meet the exemption criteria from premarket notification requirements. However, FDA is identifying a substantial amount of these devices for exemption in table 2. Table 2--Class II Devices (Sec. 866.5750--Radioallergosorbent (RAST) Immunological Test Systems) ------------------------------------------------------------------------ Source (taxonomical Allergen code Allergen product name) ------------------------------------------------------------------------ Grass Pollens ------------------------------------------------------------------------ g1......................... Sweet vernal grass... Anthoxanthum odoratum. g3......................... Cocksfoot grass, Dactylis glomerata. Orchard grass. g4......................... Meadow fescue........ Festuca elatior. g5......................... Rye-grass (perennial Lolium perenne. rye grass). g7......................... Common reed (common Phragmites communis. reed grass). g8......................... Meadow grass, Poa pratensis. Kentucky blue (June grass). g9......................... Redtop, Bentgrass.... Agrostis stolonifera, Agrostis gigantea (Agrostis alba). g11........................ Brome grass.......... Bromus inermis. g12........................ Cultivated rye Secale cereale. (cultivated rye grass). g13........................ Velvet grass......... Holcus lanatus. g14........................ Cultivated oat Avena sativa. (cultivated oat grass). g15........................ Cultivated wheat Triticum aestivum (cultivated wheat (Triticum spp.). grass). g16........................ Meadow foxtail Alopecurus (meadow foxtail pratensis. grass). g17........................ Bahia grass.......... Paspalum notatum. g24........................ Wheat grass, Western. Agropyron smithii (Elymus smithii). g30........................ Bluegrass, annual.... Poa annua. g70........................ Wild rye grass....... Elymus triticoides, Elymus condensatus. g71........................ Canary grass......... Phalaris arundinacea. g201....................... Barley, cultivated... Hordeum vulgare. g202....................... Maize, corn Zea mays. (cultivated corn). g203....................... Salt grass........... Distichlis spicata. g204....................... False oat-grass...... Arrhenatherum elatius. g216....................... Cyn d 1.............. Cynodon dactylon. g701....................... Phl p 1.0102, Phl p Phleum pratense. 5.0101. g702....................... Phl p 7.0101......... Phleum pratense. g703....................... Phl p 12.0101........ Phleum pratense. ------------------------------------------------------------------------ Weed Pollens ------------------------------------------------------------------------ w2......................... Western ragweed...... Ambrosia psilostachya. w4......................... False ragweed........ Ambrosia acanthicarpa (Franseria acanthicarpa). w5......................... Wormwood............. Artemisia absinthium, Artemisia annua. w6......................... Mugwort.............. Artemisia vulgaris. w7......................... Marguerite, ox-eye Chrysanthemum daisy. leucanthemum. w8......................... Dandelion............ Taraxacum vulgare, Taraxacum officinale. w9......................... Plantain (English), Plantago lanceolata. Ribwort. w10........................ Goosefoot, lamb's Chenopodium album. quarters. w11........................ Saltwort (prickly), Salsola kali Russian thistle. (Salsola pestifer). w12........................ Goldenrod............ Solidago virgaurea (Solidago spp.). w13........................ Cocklebur, common.... Xanthium commune. w14........................ Common pigweed (rough Amaranthus pigweed). retroflexus. w15........................ Scale, Lenscale...... Atriplex lentiformis. [[Page 13623]] w16........................ Rough marsh elder.... Iva ciliate, Iva annua. w17........................ Firebush (Kochia).... Kochia scoparia. w18........................ Sheep sorrel......... Rumex acetosella. w19........................ Wall pellitory....... Parietaria officinalis. w20........................ Nettle (Common Urtica dioica. stinging nettle). w21........................ Wall pellitory....... Parietaria judaica. w22........................ Japanese hop Humulus japonicas (careless weed). (Humulus scandens). w23........................ Yellow dock, Yellow Rumex crispus. dockweed. w24........................ Spiny pigweed........ Amaranthus spinosus. w27........................ Carnation............ Dianthus spp. w28........................ Rose................. Rosa rugosa. w33........................ Clover............... Trifolium pratense. w35........................ Mexican tea.......... Chenopodium ambrosioides. w36........................ Rabbit bush.......... Ambrosia deltoidea (Franseria deltoides). w37........................ Salt bush, annual.... Atriplex wrightii. w39........................ Water hemp, Western.. Amaranthus rudis (Acnida tamariscina). w41........................ Burrobrush........... Hymenoclea salsola. w42........................ Poverty weed......... w43........................ Common sagebrush..... Artemisia tridentata. w45........................ Alfalfa.............. Medicago sativa. w46........................ Dog fennel........... Eupatorium capillifolium. w53........................ Geranium............. Geranium spp. w67........................ Groundsel bush....... Baccharis halimifolia. w69........................ Iodine bush.......... Allenrolfea occidentalis. w70........................ Ragweed, slender..... Ambrosia confertiflora. w75........................ Wing scale Atriplex canescens. (wingscale). w82........................ Careless weed........ Amaranthus palmeri, Amaranthus hybridus. w90........................ Japanese hop......... Humulus japonicas (Humulus scandens). w203....................... Rape (rape pollen)... Brassica napus. w204....................... Sunflower............ Helianthus annuus. w206....................... Camomile............. Matricaria chamomilla. w207....................... Lupin................ Lupinus spp. w210....................... Sugar-beet........... Beta vulgaris. w211....................... Par j 2.0101......... Parietaria judaica. w231....................... Art v 1.............. Artemisia vulgaris (Mugwort). w232....................... Sal k 1.............. Salsola kali. w233....................... Art v 3.............. Artemisa vulgaris (LTP, Mugwort). w234....................... Pla l 1.............. Plantago lanceolata. w235....................... Che a 1.0101......... Chenopodium album. w236....................... Mer a 1.0101......... Mercurialis annua. a753....................... Art v 1.............. Artemisia vulgaris (Mugwort weed). ------------------------------------------------------------------------ Tree Pollens ------------------------------------------------------------------------ t1......................... Box-elder (Maple).... Acer negundo, Acer saccharum. t2......................... Gray alder, speckled Alnus incana. alder (alder). t4......................... Hazel, hazelnut...... Corylus avellana, Corylus americana. t5......................... American beech Fagus grandifolia (beech). (Fagus americana). t6......................... Mountain juniper, Juniperus ashei Mountain cedar. (Juniperus sabinoides). t8......................... Elm.................. Ulmus americana. t9......................... Olive................ Olea europaea. t10........................ Walnut............... Juglans californica, Juglans nigra. t11........................ Maple leaf sycamore, Platanus acerifolia. London plane, Plane tree. t61........................ Sycamore............. Platanus occidentalis. t12........................ Willow............... Salix caprea, Salix nigra. t14........................ Cottonwood (Eastern Populus deltoides. Cottonwood/Black Cottonwood). t15........................ White ash............ Fraxinus americana. t16........................ White pine........... Pinus strobus. t18........................ Eucalyptus, gum-tree. Eucalyptus globulus (Eucalyptus spp.). t19/t26.................... Acacia............... Acacia longifolia (Acacia spp.). t20........................ Mesquite............. Prosopis glandulosa/ Prosopis juliflora. t21........................ Melaleuca, cajeput Melaleuca tree. quinquenervia (Melaleuca leucadendron). t22........................ Pecan, hickory....... Carya illinoinensis (Carya pecan). t23........................ Italian/Mediterranean/ Cupressus funeral cypress. sempervirens. t24........................ Japanese cypress..... Chamaecyparis obtusa (Chamaecyparis spp.). t25........................ Ash.................. Fraxinus excelsior. t27........................ Maple, red........... Acer rubrum. t29........................ Acacia............... Acacia spp. t30........................ Birch, white......... Betula populifolia. [[Page 13624]] t32........................ Willow, black........ Salix nigra. t33........................ Ash, Arizona......... Fraxinus velutina. t35........................ Cedar, salt.......... Tamarix gallica. t37........................ Bald cypress (white Taxodium distichum. bald cypress). t38........................ Elm, Chinese/Siberian Ulmus pumila. t40........................ Hazelnut tree........ Corylus americana. t41........................ White hickory........ Carya alba (Carya tomentosa). t42........................ Oak, red............. Quercus rubra. t43........................ Loblolly pine........ Pinus taeda. t44........................ Hackberry............ Celtis occidentalis. t45........................ Cedar elm............ Ulmus crassifolia. t47........................ Juniper, one seed.... Juniperus monosperma. t48........................ Pine, lodgepole...... Pinus contorta. t49........................ Pine, ponderosa...... Pinus ponderosa. t50........................ Beech, European...... Fagus sylvatica. t51........................ Tree of Heaven....... Ailanthus altissima. t52........................ Western white pine... Pinus monticola. t54........................ Russian olive........ Elaeagnus angustifolia. t55........................ Scotch broom......... Cytisus scoparius. t56........................ Bayberry............. Myrica cerifera. t57........................ Red cedar............ Juniperus virginiana. t60........................ Western juniper...... Juniperus occidentalis. t61........................ Sycamore............. Platanus occidentalis. t70........................ Mulberry (white Morus alba. mulberry). t71........................ Red mulberry......... Morus rubra. t72........................ Queen palm........... Arecastrum romanzoffiamon. t73........................ Australian pine...... Casuarina equisetifolia. t77........................ Oak mix (red, white, Quercus spp. black). t80........................ Japanese cypress..... Chamaecyparis obtusa. t81........................ Japanese alder....... Alnus japonica. t83........................ Mango tree........... Mangifera indica. t90........................ Walnut, black........ Juglans nigra. t96........................ Poplar, white Populus alba. (poplar). t103/t218.................. Virginia live oak Quercus virginiana. (live oak). t105....................... Pepper tree.......... Schinus molle. t110....................... Orange tree.......... Citrus sinensis. t201....................... Spruce, Norway spruce Picea abies (Picea excelsa). t202....................... Alder, smooth........ Alnus incana spp. Rugosa (Alnus rugosa). t203....................... Horse chestnut....... Aesculus hippocastanum. t205....................... Elder................ Sambucus nigra. t206....................... Chestnut............. Castanea sativa. t207....................... Douglas fir.......... Pseudotsuga menziesii (Pseudotsuga taxifolia). t208....................... Linden............... Tilia cordata. t209....................... Horn beam............ Carpinus betulus. t210....................... Privet............... Ligustrum vulgare. t211....................... Sweet gum............ Liquidambar styraciflua. t212....................... Cedar................ Libocedrus decurrens. t213....................... Pine................. Pinus radiata. t214....................... Date palm............ Phoenix canariensis. t215....................... Lilac................ Syringa vulgaris. t217....................... Pepper tree.......... Schinus molle. t217....................... Red alder............ Alnus rubra. t218....................... Virginia live oak.... Quercus virginiana. t218....................... Bayberry (bayberry/ Myrica gale. sweet gale). t219....................... Palo verde........... Cercidium floridum. t219....................... Red cedar............ Juniperus virginiana. t220....................... Bet v 4.............. Betula verrucosa (Birch). t221....................... Bet v 2.0101, Bet v 4 Betula verrucosa (Birch). t222....................... Cypress (Arizona Cupressus arizonica. cypress). t223....................... Oil palm............. Elaeis guineensis. t224....................... Ole e 1.............. Olea europaea. t225....................... Bet v 6.............. Betula verrucosa (Birch). t226....................... Cup a 1.............. Cupressus arizonica. t227....................... Ole e 7.............. Olea Europaea. t228....................... Aspen, quaking....... Populus tremuloides. t229....................... Eastern hemlock...... Tsuga canadensis. t230....................... Redwood (sequoia).... Sequoia sempervirens. t232....................... Pussy willow......... Salix discolor. t240....................... Ole e 9.0101......... Olea Europaea. t241....................... Pla a 1.0101......... Platanus acerifolia. [[Page 13625]] t242....................... Pla a 2.............. Platanus acerifolia. t243....................... Pla a 3.0101......... Platanus acerifolia. t244....................... Cor a 1.0103......... Corylus avellana. t245....................... Aln g 1.0101......... Alnus glutinosa. t246....................... Cry j 1.............. Cryptomeria japonica. t280....................... Locust tree.......... Robinia pseudoacacia. t401....................... Brazilian peppertree. Schinus terebinthifolius. t402....................... Mastic tree.......... Pistacia lentiscus. t404....................... Tree of heaven....... Ailanthus altissima. t406....................... Date palm............ Phoenix dactylifera. a482....................... Ole e 1.............. Olea europaea (Olive Oil). ------------------------------------------------------------------------ Mites ------------------------------------------------------------------------ d207....................... Blo t 5.0101......... Blomia tropicalis. d208....................... Lep d 2.0101......... Lepidoglyphus destructor. ------------------------------------------------------------------------ Microorganisms, Molds, Yeast ------------------------------------------------------------------------ m1......................... Penicillium Penicillium chrysogenum chrysogenum (Penicillium (Penicillium notatum). notatum). m2......................... Cladosporium herbarum Cladosporium (Hormodendrum). herbarum (Hormodendrum). m3......................... Aspergillus fumigatus Aspergillus fumigatus. m4......................... Mucor racemosus...... Mucor racemosus. m5......................... Candida albicans..... Candida albicans. m7......................... Botrytis cinerea..... Botrytis cinerea. m8......................... Drechslera halodes Drechslera halodes (Setomelanomma (Setomelanomma rostrata, rostrata, Helminthosporium Helminthosporium halodes, halodes). Helminthosporium interseminatum). m9......................... Fusarium moniliforme Fusarium moniliforme (Fusarium (Fusarium proliferatum). proliferatum). m10........................ Stemphylium botryosum Stemphylium herbarum (Stemphylium botryosum). m11........................ Rhizopus nigricans... Rhizopus nigricans. m12........................ Aureobasidium Aureobasidium pullulans. pullulans. m13........................ Phoma betae.......... Phoma betae. m14........................ Epicoccum Epicoccum purpurascens. purpurascens (Epicoccum nigrum). m15........................ Trichoderma viride... Trichoderma viride. m16........................ Curvularia lunata.... Curvularia lunata Curvularia specifera (K923044). m17........................ Cladosporium fulvum.. Cladosporium fulvum. m18........................ Fusarium culmorum.... Fusarium culmorum. m19........................ Aspergillus Aspergillus versicolor. versicolor. m20........................ Mucor mucedo......... Mucor mucedo. m21........................ Aspergillus clavatus. Aspergillus clavatus. m22........................ Micropolyspora faeni. Saccharopolyspora rectivirgula (Micropolyspora faeni). m23........................ Thermoactinomyces Thermoactinomyces vulgaris. vulgaris. m24........................ Stachybotrys atra.... Stachybotrys chartarum (Stachybotrys atra). m24........................ Paecilomyces spp..... Paecilomyces spp. m25........................ Aspergillus Aspergillus versicolor. versicolor. m25........................ Penicillium Penicillium brevicompactum. brevicompactum. m26........................ Cladosporium Cladosporium cladosporioides. cladosporioides. m26........................ Penicillium citrinum. Penicillium citrinum. m27........................ Penicillium spp...... Penicillium spp. m29........................ Aspergillus repens... Aspergillus repens. m30........................ Penicillium Penicillium roqueforti. roqueforti. m32........................ Cladosporium Cladosporium cladosporioides. cladosporioides. m34........................ Serpula lacrymans.... Serpula lacrymans. m36........................ Aspergillus terreus.. Aspergillus terreus. m37........................ Trichophyton Trichophyton mentagrophytes. mentagrophytes. m40........................ Aspergillus Aspergillus amstelodami. amstelodami. m43........................ Saccharomyces Saccharomyces carlsberg. carlsbergensis. m44........................ Saccharomyces Saccharomyces cerevisiae. cerevisiae. m45........................ Hormodendrum hordei.. Hormodendrum hordei. m46........................ Bipolaris spicifera.. Bipolaris spicifera. m47........................ Aspergillus nidulans. Aspergillus nidulans. m48........................ Aspergillus oryzae... Aspergillus oryzae. m49........................ Fusarium oxysporum... Fusarium oxysporum. m50........................ Micropolyspora faeni. Saccharopolyspora rectivirgula (Micropolyspora faeni). m51........................ Thermoactinomyces Thermoactinomyces vulgaris. vulgaris. m53........................ Microspora canis..... Microsporum canis (Microspora canis). m54........................ Aspergillus flavus... Aspergillus flavus. m63........................ Helminthosporium Helminthosporium intersemin. intersemin. m66........................ Mucor plumbeus....... Mucor plumbeus. [[Page 13626]] m67........................ Mycogone............. Mycogone perniciosa. m68........................ Nigrospora oryzae.... Nigrospora oryzae. m69........................ Rhodotorula.......... Rhodotorula rubra (Rhodotorula mucilaginosa). m70........................ Malassezia furfur Malassezia furfur (Pityrosporum (Pityrosporum orbiculare). orbiculare). m71........................ Spondylocladium...... Spondylocladium spp. m72........................ Epidermophyton....... Epidermophyton floccosum. m73........................ Epicoccum nigrum..... Epicoccum purpurascens (Epicoccum nigrum). m80........................ Staphylococcal Staphylococcus enterotoxin A (Sta a aureus. SEA). m80........................ Helminthosporium spp. Helminthosporium spp. m81........................ Staphylococcal Staphylococcus enterotoxin B (Sta a aureus. SEB). m88........................ Stemphylium solani... Stemphylium solani. m93........................ Gliocladium Gliocladium fimbriatum. fimbriatum. m94........................ Phycomyces Phycomyces blakesleeanus. blakesleeanus. m201....................... Tilletia tritici Tilletia tritici (Ustilago nuda, (Ustilago nuda, Ustilago tritici) Ustilago tritici). (Barley smut). m202....................... Acremonium kiliense Acremonium kiliense (Cephalosporium (Cephalosporium acremonium). acremonium). m203....................... Trichosporon Trichosporon pullulans. pullulans. m204....................... Ulocladium chartarum. Ulocladium chartarum. m205....................... Trichophyton rubrum.. Trichophyton rubrum. m207....................... Aspergillus niger.... Aspergillus niger. m208....................... Chaetomium globosum.. Chaetomium globosum. m209....................... Penicillium Penicillium glabrum frequentans. (Penicillium frequentans). m209....................... Stachybotrys Stachybotrys chartarum. chartarum (Stachybotrys atra). m210....................... Trichophyton Trichophyton mentagrophytes var. mentagrophytes var. goetzii. goetzii. m211....................... Trichophyton Trichophyton mentagrophytes var. mentagrophytes var. interdigitale. interdigitale. m211....................... Oat smut............. Ustilago avenae. m212....................... Micropolyspora faeni. Saccharopolyspora rectivirgula (Micropolyspora faeni). m212....................... Geotrichum candidum.. Geotrichum candidum. m213....................... Bermuda grass smut... Ustilago cynodontis. m214....................... Johnson grass smut... Sphacelotheca cruenta. m215....................... Corn smut............ Ustilago maydis. m218....................... Asp f 1.0101......... Aspergillus fumigatus. a3050...................... Asp r 1.............. Aspergillus restrictus. m219....................... Asp f 2.............. Aspergillus fumigatus. m220....................... Asp f 3.0101......... Aspergillus fumigatus. m221....................... Asp f 4.............. Aspergillus fumigatus. m222....................... Asp f 6.0101......... Aspergillus fumigatus. m223....................... Staphylococal Staphylococus enterotoxin C (Sta a aureus. SEC). m224....................... Staphylococcal Staphylococcus enterotoxin D (Sta a aureus. SED). m226....................... Staphylococcal Staphylococcus enterotoxin TSST aureus. (Sta a TSST). m227....................... Malassezia spp. Malassezia spp. (Pityrosporum spp.). (Pityrosporum spp.). m228....................... Aspergillus flavus. .................... m229....................... Alt a 1.0101......... Alternaria alternata (Alternaria tenuis). m230....................... Alt a 6.0101......... Alternaria alternata (Alternaria tenuis). m231....................... Cla h 8.0101......... Cladosporium herbarum (Hormodendrum). m300....................... Eurotium spp......... Eurotium spp. m304....................... Aspergillus oryzae... Aspergillus oryzae. m305....................... Penicillium Penicillium brevicompactum. brevicompactum. m309....................... Aspergillus terreus.. Aspergillus terreus. m310....................... Aspergillus nidulans. Aspergillus nidulans. m311....................... Aspergillus flavus... Aspergillus flavus. m312....................... Aspergillus clavatus. Aspergillus clavatus. ------------------------------------------------------------------------ Epidermal & Animal ------------------------------------------------------------------------ e6......................... Guinea pig epithelium Cavia porcellus. e7......................... Pigeon droppings..... Columba palumbus, Columba livia. e25........................ Chicken serum........ Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26........................ Parrot serum......... Psittacoidea spp. e62........................ Camel................ Camelus dromedaries. e70........................ Goose feathers....... Anser anser. e71........................ Mouse epithelium..... Mus musculus (Mus spp.). e73........................ Rat epithelium....... Rattus norvegicus. e74........................ Rat urine proteins... Rattus norvegicus Rattus rattus. e75........................ Rat serum proteins... Rattus norvegicus Rattus rattus. e76........................ Mouse serum proteins. Mus musculus (Mus spp.). e77........................ Budgerigar droppings. Melopsittacus undulatus. e78........................ Budgerigar feathers.. Melopsittacus undulatus. e79........................ Budgerigar serum Melopsittacus proteins. undulatus. e80........................ Goat epithelium...... Capra hircus. [[Page 13627]] e81........................ Sheep epithelium..... Ovis aries (Ovis spp.). e82........................ Rabbit epithelium.... Oryctolagus cuniculus (Oryctolagus spp.). e83........................ Swine epithelium..... Sus scrofa (Sus scrofa domesticus; Sus spp.). e84........................ Hamster epithelium... Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. e85........................ Chicken feathers..... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86........................ Duck feathers........ Anas platyrhynchos. e87........................ Rat epithelium, serum Rattus norvegicus proteins, and urine Rattus rattus. proteins. e88........................ Mouse epithelium, Mus musculus (Mus serum proteins, and spp.). urine proteins (mouse). e89........................ Turkey feathers...... Meleagris gallopavo. e90........................ Budgerigar serum Melopsittacus proteins, feathers, undulatus. and droppings. e91........................ Pigeon serum Streptopelia proteins, feathers, roseogrisea and droppings. Psittacidae spp. e92........................ Parrot serum Ara spp. proteins, feathers, and droppings. e93........................ Pigeon serum proteins Streptopelia roseogrisea. e94........................ Fel d 1.0101......... Felis domesticus. a345....................... Fel d 1.............. Felis domesticus. e98........................ Parrot droppings..... Psittacoidea spp. e101....................... Can f 1.0101......... Canis familiaris (Canis domesticus). a174....................... Can f 1.............. Canis familiaris (Canis domesticus). e102....................... Can f 2.0101......... Canis familiaris (Canis domesticus). e196....................... Parakeet feathers.... Nymphicus hollandicus. e197....................... Parakeet droppings... Nymphicus hollandicus. e198....................... Parakeet serum....... Nymphicus hollandicus. e199....................... Canary bird serum.... Serinus canarius. e200....................... Canary bird droppings Serinus canarius. e201....................... Canary bird feathers Serinus canarius. (Canary feathers). e202....................... Reindeer epithelium.. Rangifer tarandus. e203....................... Mink epithelium...... Mustela spp. e204....................... Bos d 6.............. Bos domesticus (Bos taurus; Bos spp.). e205....................... Horse, serum proteins Equus caballus (Equus spp.). e206....................... Rabbit, serum Oryctolagus proteins. cuniculus (Oryctolagus spp.). e208....................... Chinchilla epithelium Chinchilla laniger. e209....................... Gerbil epithelium.... Meriones unguiculatus. e210....................... Fox epithelium....... Vulpes vulpes. e211....................... Rabbit, urine Oryctolagus proteins. cuniculus (Oryctolagus spp.). e212....................... Swine, urine proteins Sus scrofa (Sus scrofa domesticus; Sus spp.). e213....................... Parrot feathers...... Ara spp. e214....................... Finch feathers....... Lonchura domestica. e215....................... Pigeon feathers...... Streptopelia roseogrisea (Streptopelia spp.), Columbia spp. e216....................... Deer epithelium...... Dama dama. e217....................... Ferret epithelium.... Mustela putorius. e218....................... Chicken droppings.... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219....................... Chicken, serum Gallus domesticus proteins. (Gallus gallus domesticus; Gallus spp.). e220....................... Fel d 2, Cat serum Felis domesticus. albumin. e221....................... Can f 3.............. Canis familiaris (Canis domesticus) (Dog serum albumin). e222....................... Swine serum albumin Sus scrofa (Sus (Sus s PSA). scrofa domesticus; Sus spp.). e225....................... Lovebird feathers.... Psittacoidea agapomis. e226....................... Can f 5.0101......... Canis familiaris. e227....................... Equ c 1.0101......... Equus caballus. e228....................... Fel d 4.0101......... Felis domesticus. e230....................... Equ c 3.............. Equus caballus. e231....................... Mus m 1.............. Mus musculus. ------------------------------------------------------------------------ Food ------------------------------------------------------------------------ f9......................... Rice................. Oryza sativa. f12........................ Pea (green pea)...... Pisum sativum. f15........................ White bean........... Phaseolus vulgaris. f19........................ Cayenne pepper....... Capsicum frutescens, (Capsicum annum). f21........................ Sugar cane........... Saccharum officinarum. f22........................ Raspberry............ Rubus idaeus. f26........................ Pork................. Sus scrofa (Sus scrofa domesticus; Sus spp.). f29........................ Watermelon........... Citrullus lanatus (Citrullus vulgaris). f31........................ Carrot............... Daucus carota. f32........................ Oyster mushroom...... Pleurotus ostreatus. [[Page 13628]] f33........................ Orange............... Citrus sinensis. f35........................ Potato............... Solanum tuberosum. f43........................ Mother's milk........ Homo sapiens. f44........................ Strawberry........... Fragaria vesca (Fragaria spp.). f45........................ Yeast, baker's....... Saccharomyces cerevisiae. f46........................ Pepper, Red.......... Capsicum annuum. f47........................ Garlic............... Allium sativum. f48........................ Onion................ Allium cepa. f49........................ Apple................ Malus x domestica (Malus spp.). f51........................ Bamboo shoot......... Phyllostachys pubescens. f52........................ Cacao/chocolate...... Theobroma cacao. f54........................ Sweet potato......... Ipomoea batatas. f55........................ Common millet........ Panicum miliaceum. f56........................ Foxtail millet....... Setaria italica. f57........................ Japanese millet...... Echinochloa crus- galli. f58........................ Pacific squid........ Todarodes pacificus. f59........................ Octopus.............. Octopus vulgaris (Octopus spp.). f63........................ Kefir................ NA. f67........................ Parmesan cheese...... NA. f81........................ Cheese, cheddar type. NA. f82........................ Cheese, mold type.... NA. f83........................ Chicken.............. Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86........................ Parsley.............. Petroselinum crispum. f87........................ Melon................ Cucumis melo Cucumis melo + Citrullus lanatus. f88........................ Mutton (lamb)........ Ovis aries (Ovis spp.). f90........................ Malt................. Hordeum vulgare. f92........................ Banana............... Musa spp. f93........................ Cacao................ Theobroma cacao. f94........................ Pear................. Pyrus communis (Pyrus spp.). f97........................ Yam.................. Dioscorea spp., Dioscorea opposita. f97........................ Chamomile tea........ Matricaria chamomilla. f98........................ Gliadin.............. Triticum aestivum (Triticum spp.). f102....................... Cantaloupe........... Cucumis melo var. cantalupensis. f105....................... Chocolate............ Theobroma cacao. f109....................... Cottonseed........... Gossypium hirsutum. f110....................... Giant radish......... Raphanus sativus. f118....................... Zucchini............. Cucurbita pepo. f119....................... Radish............... Raphanus sativus. f120....................... Venison.............. Capreolus capeolus. f121....................... Pinto bean........... Phaseolus vulgaris. f122....................... Cheese, American..... NA. f127....................... Black-eyed pea....... Vigna unguiculata. f131....................... Black Olive.......... Olea europaea. f136....................... Red beet............. Beta vulgaris var. conditiva. f139....................... Goat's Cheese........ Capra aegagrus. f140....................... Bran................. NA. f141....................... Corn (vegetables).... Zea mays. f152....................... Green bell pepper.... Capsicum annuum. f155....................... Brewer's yeast....... Saccharomyces carlsbergensis. f157....................... Duck................. Anas domesticus. f158....................... Goose................ Anser anser. f160....................... Camembert cheese..... NA. f162....................... Nectarine............ Prunus persica var. nucipersica. f163....................... Kohlrabi............. Brassica oleracea var. gongylodes. f65........................ Perch .................... f166....................... Leek................. Allium porrum. f170....................... Cheese (Switzerland) NA. (Swiss cheese). f174....................... Fig.................. Ficus carica. f177....................... Cranberry............ Vaccinium macrocarpon. f179....................... Raisin............... Vitis spp. f182....................... Lima bean............ Phaseolus lunatus. f198....................... Flaxseed (bruised Linum usitatissimum. grain). f199....................... Untreated native milk Bos domesticus (Bos taurus; Bos spp.). f208....................... Lemon................ Citrus limon. f209....................... Grapefruit........... Citrus paradisi. f210....................... Pineapple............ Ananas comosus. f211....................... Blackberry........... Rubus fruticosus. f212....................... Mushroom (champignon) Agaricus hortensis (Agaricus spp.). f213....................... Rabbit............... Oryctolagus cuniculus (Oryctolagus spp.). [[Page 13629]] f214....................... Spinach.............. Spinacia oleracea. f215....................... Lettuce.............. Lactuca sativa. f216....................... Cabbage.............. Brassica oleracea var. capitata. f217....................... Brussels sprouts..... Brassica oleracea var. gem. f218....................... Paprika, sweet pepper Capsicum annuum. f219....................... Fennel seed.......... Foeniculum vulgare. f219....................... Sage................. Salvia officinalis. f220....................... Cinnamon............. Cinnamomum spp. f221....................... Coffee............... Coffea spp. f222....................... Tea.................. Camellia sinensis. f223....................... Green olive.......... Olea europaea. f225....................... Summer squash, Cucurbita pepo. pumpkin. f225....................... Pumpkin.............. Cucurbita maxima. f226....................... Pumpkin seed......... Cucurbita pepo. f227....................... Sugar-beet seed...... Beta vulgaris. f229....................... Safflower Seed....... Carthamus tinctorius. f231....................... Milk, boiled......... Bos domesticus (Bos taurus; Bos spp.). f234....................... Vanilla.............. Vanilla planifolia. f237....................... Apricot.............. Prunus armeniaca. f241....................... Gouda cheese......... NA. f242....................... Cherry............... Prunus avium. f244....................... Cucumber............. Cucumis sativus. f246....................... Guar, guar gum....... Cyamopsis tetragonoloba. f247....................... Honey................ NA. f248....................... Rosemary............. Rosmarinus officinalis. f254....................... Plaice............... Pleuronectes platessa. f255....................... Plum................. Prunus domestica, Prunus americana. f258....................... Squid................ Loligo spp. f259....................... Grape................ Vitis vinifera (Vitis spp.). f260....................... Broccoli............. Brassica oleracea var. italica (Brassica oleracea var. cultivar). f261....................... Asparagus............ Asparagus officinalis. f262....................... Aubergine, eggplant.. Solanum melongena. f263....................... Green pepper......... Piper nigrum, Capsicum annuum. f264....................... Eel.................. Anguilla anguilla. f265....................... Caraway.............. Carum carvi. f265....................... Cumin................ Cuminum cyminum. f266....................... Mace................. Myristica fragrans. f267....................... Cardamon............. Elettaria cardamomum. f268....................... Clove................ Syzygium aromaticum. f269....................... Basil................ Ocimum basilicum. f270....................... Ginger............... Zingiber officinale. f271....................... Anise................ Pimpinella anisum. f272....................... Tarragon............. Artemisia dracunculus. f273....................... Thyme................ Thymus vulgaris. f274....................... Marjoram............. Origanum majorana. f275....................... Lovage............... Levisticum officinale. f276....................... Fennel, fresh........ Foeniculum vulgare. f277....................... Dill................. Anethum graveolens. f278....................... Bay leaf............. Laurus nobilis. f279....................... Chili pepper......... Capsicum frutescens. f280....................... Black pepper......... Piper nigrum. f281....................... Curry (Santa Maria).. NA. f282....................... Nutmeg............... Myristica fragrans. f283....................... Oregano.............. Origanum vulgare. f284....................... Turkey meat.......... Meleagris gallopavo. f285....................... Elk/moose meat....... Alces spp. f286....................... Mare's milk.......... Equus caballus (Equus spp.). f287....................... Red kidney bean...... Phaseolus vulgaris. f288....................... Blueberry............ Vaccinium myrtillus (Vaccinium spp.). f289....................... Date................. Phoenix dactylifera. f291....................... Cauliflower.......... Brassica oleracea var. botrytis. f292....................... Guava................ Psidium guajava. f293....................... Papaya............... Carica papaya. f294....................... Passion fruit, Passiflora edulis Maracuja. (Passiflora spp.). f295....................... Carambola............ Averrhoa carambola. f296....................... Carob................ Ceratonia siliqua. f297....................... Gum arabic........... Acacia senegal (Acacia spp.). f298....................... Tragacanth........... Astragalus spp. f299....................... Sweet chestnut Castanea sativa. (chestnut). [[Page 13630]] f300....................... Pinto bean........... Phaseolus spp. f301....................... Persimmon (kaki Diospyros kaki. fruit, sharon). f302....................... Mandarin (tangerine, Citrus reticulata. clementine, satsumas). f305....................... Fenugreek............ Trigonella foenum- graecum. f306....................... Lime................. Citrus aurantifolia. f307....................... Hake................. Merluccius merluccius. f308....................... Sardine (pilchard)... Sardina pilchardus. f310....................... Blue vetch........... Lathyrus sativus. f311....................... Megrim............... Lepidorhombus whiffiagonis. f315....................... Green bean........... Phaseolus vulgaris. f316....................... Rape seed............ Brassica napus. f317....................... Coriander............ Coriandrum sativum. f318....................... Jack fruit........... Artocarpus heterophyllus. f319....................... Beetroot............. Beta vulgaris. f320....................... Crayfish............. Astacus astacus. f321....................... Horse meat........... Equus caballus (Equus spp.). f322....................... Red currant.......... Ribes sylvestre. f324....................... Hop (fruit cone)..... Humulus lupulus. f325....................... Saffron.............. Colchicum autumnale. f328....................... Fig.................. Ficus carica. f329....................... Watermelon........... Citrullus lanatus. f330....................... Rose hip............. Rosa spp. f331....................... Saffron.............. Crocus sativus. f332....................... Mint................. Mentha piperita. f333....................... Linseed.............. Linum usitatissimum. f336....................... Jujube............... Ziziphus jujuba. f336....................... Wine vinegar......... Vitis vinifera (Vitis spp.). f337....................... Sole................. Solea solea. f337....................... English sole......... Parophrys vetulus. f338....................... Wine, white.......... Vitis vinifera (Vitis spp.). f339....................... Allspice............. Pimenta dioica. f339....................... Wine, red............ Vitis vinifera (Vitis spp.). f341....................... Cranberry............ Vaccinium oxycoccus, Vaccinium macrocarpon. f342....................... Olive (black, fresh). Olea europaea. f343....................... Raspberry............ Rubus idaeus. f344....................... Sage................. Salvia officinalis. f346....................... Chives............... Allium schoenoprasum. f347....................... Quinoa............... Chenopodium quinoa. f348....................... Litchi............... Litchi chinensis. f349....................... Chum salmon roe...... Oncorhynchus keta. f358....................... Artichoke............ Cynara scolymus. f360....................... Yogurt............... NA. f368....................... Black bass........... Micropterus dolomieu (Micropterus dolomieui). f374....................... Karaya gum........... Sterculia urens. f375....................... Horseradish.......... Armoracia rusticana. f377....................... Maple syrup.......... NA. f379....................... Okra................. Abelmoschus esculentus. f382....................... Beet, sugar.......... Beta vulgaris var. altissima. f401....................... Loquat............... Eriobotrya japonica. f402....................... Fig.................. Ficus carica. f403....................... Brewer's yeast....... Saccharomyces cerevisiae. f405....................... Mint................. Mentha spp. f406....................... Arugula.............. Eruca vesicaria. ------------------------------------------------------------------------ House Dust ------------------------------------------------------------------------ h1......................... Greer Labs., Inc..... NA. h2......................... Hollister-Stier Labs. NA. h6......................... Japan................ NA. ------------------------------------------------------------------------ Venoms & Insects ------------------------------------------------------------------------ i7......................... Midge................ Chironomus yoshimatsui. i8......................... Moth................. Bombyx mori, Heterocera spp. i47........................ Water flea........... Daphnia spp. i49........................ Deer fly............. Chrysops spp. i51........................ Black ant............ Camponotus pennsylvanicus. i54........................ Flea mix (dog/cat), Ctenocephalides spp. common flea. i71........................ Mosquito............. Aedes communis, Aedes spp. and Culex spp. i72........................ Green nimitti........ Cladotanytarsus lewisi. [[Page 13631]] i73........................ Blood worm........... Chironomus thummi, Chironomusri parius, Chironomus spp. i75........................ European hornet...... Vespa crabro. i76........................ Berlin beetle........ Trogoderma angustum. i77........................ European paper wasp.. Polistes dominulus. i78........................ Fly.................. Musca domestica. i80........................ Bumblebee............ Bombus pennsylvanicus. i201....................... Horse bot fly........ Gasterophilus intestinalis. i202....................... Grain weevil......... Sitophilus granarius. i203....................... Mediterranean flour Ephestia kuehniella moth. (Anagasta kuehniella). i204....................... Horse fly............ Tabanus spp. i205....................... Bumblebee............ Bombus terrestris. i208....................... Api m 1.0101......... Apis mellifera. a45........................ Api m 1.............. Apis mellifera. i209....................... Ves v 5.0101......... Vespula vulgaris. a670....................... Ves v 5.............. Vespula vulgaris. i210....................... Pol d 5.0101......... Polistes dominulus. i211....................... Ves v 1.0101......... Vespula vulgaris. i213....................... Api m 4.............. Apis mellifera. i214....................... Api m 2.............. Apis mellifera. i215....................... Api m 3.............. Apis mellifera. i216....................... Api m 5.............. Apis mellifera. i217....................... Api m 10............. Apis mellifera. i220....................... Bla g 1.0101......... Blattella germanica. i221....................... Bla g 2.0101......... Blattella germanica. i222....................... Bla g 5.0101......... Blattella germanica. i223....................... Bla g 7.............. Blattella germanica. a46........................ Api m 2.............. Apis mellifera. ------------------------------------------------------------------------ Miscellaneous ------------------------------------------------------------------------ o1......................... Cotton, crude fibers. Gossypium spp. o3......................... Cotton (treated)..... Gossypium spp. o70........................ Seminal fluid........ Homo sapiens. o71........................ Staphylococcus aureus Staphylococcus aureus. o72........................ Pichia pastoris crude Pichia pastoris. extract customer specific. o72........................ Sperm-sediment....... Homo sapiens. o73........................ Pichia pastoris crude Pichia pastoris. extr. vector customer specific. o74........................ Pichia pastoris with Pichia pastoris. vector customer specific. o201....................... Tobacco leaf, tobacco Nicotiana tabacum. dust. o202....................... Artemia salina, fish Artemia salina. feed. o203....................... Tetramin, fish feed.. NA. o207....................... Daphnia, fish feed... Daphnia spp. o211....................... Mealworm............. Tenebrio molitor. o212....................... Streptavidin......... Streptomyces avidini. o213....................... MBP (maltose binding Escherichia coli. protein). o214....................... CCD; MUXF3 from Ananas comosus. bromelain. o72........................ Enterotoxin A (Sta a Staphylococcus SEA). aureus. o73........................ Enterotoxin B (Sta a Staphylococcus SEB). aureus. ------------------------------------------------------------------------ Parasites ------------------------------------------------------------------------ p1......................... Ascaris.............. Ascaris suum. p2......................... Echinococcus......... Echinococcus granulosus. p3......................... Schistosoma.......... Schistosoma mansoni. p4......................... Anisakis (Herring Anisakis simplex Worm). (Anisakis spp.). p5......................... Toxocara canis....... Toxocara canis. p10........................ Ani s 3.0101......... Anisakis simplex (Anisakis spp.). p11........................ Ani s 1.............. Anisakis simplex (Anisakis spp.). ------------------------------------------------------------------------ Occupational ------------------------------------------------------------------------ k4......................... Threshing dust....... NA. k5......................... Flax................. NA. k7......................... Hay Dust............. NA. k8......................... Hop (hops)........... Humulus lupulus. k12........................ Grain mill dust...... NA. k14........................ Kapok................ NA. k20........................ Sheep's wool Ovis aries (Ovis (treated) (wool). spp.). k21........................ Sheep's wool Ovis aries (Ovis (Untreated). spp.). [[Page 13632]] k23........................ Straw Dust........... NA. k33........................ Oak.................. NA. k70........................ Green coffee bean.... Coffea spp. k71........................ Castor bean.......... Ricinus communis. k72........................ Ispaghula............ Plantago psyllium/ Plantago ovata. k73........................ Silk waste........... NA. k74........................ Silk................. Bombyx mori. k75........................ Isocyanate TDI NA. (Toluene diisocyanate). k76........................ Isocyanate MDI NA. (Diphenylmethane diisocyanate). k77........................ Isocyanate HDI NA. (Hexamethylen diisocyanate). k78........................ Ethylene oxide....... NA. k79........................ Phthalic anhydride... NA. k80........................ Formaldehyde/Formalin NA. k81........................ Ficus................ Ficus benjamina (Ficus spp.). k83........................ Cotton seed.......... Gossypium hirsutum. k84........................ Sunflower seed....... Helianthus annuus. k85........................ Chloramin T.......... NA. k86........................ Trimellitic NA. anhydride, TMA. k87........................ Asp o 21, alpha- Aspergillus oryzae. amylase. k89........................ Orris root........... Iris florentina. k99........................ HSA (Human Serum Homo sapiens. Albumin) (Hom s HSA). k201....................... Car p 1, Papain...... Carica papaya. k202....................... Ana c 2, Bromelain... Ananas comosus. k204....................... Maxatase............. Bacillus licheniformis. k205....................... Alcalase............. Bacillus spp. k206....................... Savinase, Protease 1 Bacillus spp. (Bac l Subtilisin). k208....................... Gal d 4, Lysozyme.... Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209....................... Hexahydrophtalic NA. anhydrid. k210....................... Maleic anhydride..... NA. k211....................... Methyltetrahydrophtal NA. ic anhydrid. k212....................... Abachi wood dust..... Triplochiton scleroxylon. k213....................... Pepsin (Sus s Pepsin) Sus scrofa (Sus scrofa domesticus; Sus spp.). k213....................... TCPA................. NA. k214....................... Bougainvillea........ Bougainvillea spp. k225....................... Horse radish Armoracia rusticana. peroxidase (Arm r HRP). k226....................... Ascorbate oxidase Cucurbita pepo. (Cuc p ascorbate oxidase). k301....................... Flour dust........... Triticum spp. k501....................... Savinase customer Proprietary specific. knowledge of customer. k502....................... Lipolase customer Proprietary specific. knowledge of customer. k503....................... Termamyl customer Proprietary specific. knowledge of customer. k504....................... Clazinase customer Proprietary specific. knowledge of customer. ------------------------------------------------------------------------ V. Reference The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA Guidance, ``Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,'' February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: March 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-04938 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices 13609
Agency will review this copy, including the proposed indication of management During this session, the committees will
the claimed confidential information, in of moderate to severe pain where the discuss the drug development program
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![13632 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
TABLE 2—CLASS II DEVICES (§ 866.5750—RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL TEST SYSTEMS)—
Continued
Source
Allergen code Allergen product (taxonomical name)
k23 .............................. Straw Dust ........................................................................... NA.
k33 .............................. Oak ...................................................................................... NA.
k70 .............................. Green coffee bean ............................................................... Coffea spp.
k71 .............................. Castor bean ......................................................................... Ricinus communis.
k72 .............................. Ispaghula ............................................................................. Plantago psyllium/Plantago ovata.
k73 .............................. Silk waste ............................................................................. NA.
k74 .............................. Silk ....................................................................................... Bombyx mori.
k75 .............................. Isocyanate TDI (Toluene diisocyanate) ............................... NA.
k76 .............................. Isocyanate MDI (Diphenylmethane diisocyanate) ............... NA.
k77 .............................. Isocyanate HDI (Hexamethylen diisocyanate) .................... NA.
k78 .............................. Ethylene oxide ..................................................................... NA.
k79 .............................. Phthalic anhydride ............................................................... NA.
k80 .............................. Formaldehyde/Formalin ....................................................... NA.
k81 .............................. Ficus .................................................................................... Ficus benjamina (Ficus spp.).
k83 .............................. Cotton seed ......................................................................... Gossypium hirsutum.
k84 .............................. Sunflower seed .................................................................... Helianthus annuus.
k85 .............................. Chloramin T ......................................................................... NA.
k86 .............................. Trimellitic anhydride, TMA ................................................... NA.
k87 .............................. Asp o 21, alpha-amylase ..................................................... Aspergillus oryzae.
k89 .............................. Orris root .............................................................................. Iris florentina.
k99 .............................. HSA (Human Serum Albumin) (Hom s HSA) ...................... Homo sapiens.
k201 ............................ Car p 1, Papain ................................................................... Carica papaya.
k202 ............................ Ana c 2, Bromelain .............................................................. Ananas comosus.
k204 ............................ Maxatase ............................................................................. Bacillus licheniformis.
k205 ............................ Alcalase ............................................................................... Bacillus spp.
k206 ............................ Savinase, Protease 1 (Bac l Subtilisin) ............................... Bacillus spp.
k208 ............................ Gal d 4, Lysozyme ............................................................... Gallus domesticus (Gallus gallus domesticus; Gallus
spp.).
k209 ............................ Hexahydrophtalic anhydrid .................................................. NA.
k210 ............................ Maleic anhydride .................................................................. NA.
k211 ............................ Methyltetrahydrophtalic anhydrid ......................................... NA.
k212 ............................ Abachi wood dust ................................................................ Triplochiton scleroxylon.
k213 ............................ Pepsin (Sus s Pepsin) ......................................................... Sus scrofa (Sus scrofa domesticus; Sus spp.).
k213 ............................ TCPA ................................................................................... NA.
k214 ............................ Bougainvillea ........................................................................ Bougainvillea spp.
k225 ............................ Horse radish peroxidase (Arm r HRP) ................................ Armoracia rusticana.
k226 ............................ Ascorbate oxidase (Cuc p ascorbate oxidase) ................... Cucurbita pepo.
k301 ............................ Flour dust ............................................................................. Triticum spp.
k501 ............................ Savinase customer specific ................................................. Proprietary knowledge of customer.
k502 ............................ Lipolase customer specific .................................................. Proprietary knowledge of customer.
k503 ............................ Termamyl customer specific ................................................ Proprietary knowledge of customer.
k504 ............................ Clazinase customer specific ................................................ Proprietary knowledge of customer.
V. Reference Dated: March 8, 2017. input on ongoing efforts to enhance
Leslie Kux, mechanisms for patient engagement at
The following reference is on display Associate Commissioner for Policy. the Agency. Engaging with patients,
in the Division of Dockets Management [FR Doc. 2017–04938 Filed 3–13–17; 8:45 am] their caregivers, and advocates has long
(see ADDRESSES) and is available for BILLING CODE 4164–01–P been a priority of the Agency. In this
viewing by interested persons between tradition, FDA intends to enhance
9 a.m. and 4 p.m., Monday through future patient engagement by providing
Friday; it is also available electronically DEPARTMENT OF HEALTH AND a more transparent, accessible, and
at https://www.regulations.gov. FDA has HUMAN SERVICES robust experience for patient
verified the Web site address, as of the communities. To achieve these goals,
date this document publishes in the Food and Drug Administration FDA is considering establishing a new
Federal Register, but Web sites are [Docket No. FDA–2017–N–0455] Office of Patient Affairs. This concept
subject to change over time. was directly informed by the public
Enhancing Patient Engagement Efforts feedback solicited through the prior
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1. FDA Guidance, ‘‘Procedures for Class II
Device Exemptions from Premarket
Across the Food and Drug public docket regarding FDA’s
Notification, Guidance for Industry and
Administration; Establishment of a stakeholder engagement responsibilities
CDRH Staff,’’ February 19, 1998,
Public Docket; Request for Comments outlined by the Food and Drug
available at http://www.fda.gov/ ACTION: Notice; request for comments. Administration Safety and Innovation
downloads/MedicalDevices/ Act (FDASIA). The purpose of this
DeviceRegulationandGuidance/ SUMMARY: The Food and Drug notice is to outline FDA’s proposal for
GuidanceDocuments/UCM080199.pdf. Administration (FDA or Agency) is the future of patient engagement at the
establishing a public docket to solicit Agency so that the perspectives of
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Document Created: 2017-03-14 02:52:10
Document Modified: 2017-03-14 02:52:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for comments. | |
| Dates | Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. | |
| Contact | Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, 301-348-1446, email: [email protected] | |
| FR Citation | 82 FR 13609 |
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