82 FR 34848 - Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 143 (July 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 143 (July 27, 2017)
| Page Range | 34848-34850 | |
| FR Document | 2017-15858 |
[Federal Register Volume 82, Number 143 (Thursday, July 27, 2017)] [Rules and Regulations] [Pages 34848-34850] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15858] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2017-N-1917] Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective July 27, 2017. The classification was applicable on March 28, 2016. [[Page 34849]] FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations. Section 513(f)(2) of the FD&C Act, also known as De Novo classification, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of ``low-moderate risk'' or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed. In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. On December 18, 2015, Bio-Rad Laboratories, Inc., submitted a request for classification of the Amplichek II under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II 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 reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on March 28, 2016, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3920. Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an assayed quality control material for clinical microbiology assays will need to comply with the special controls named in this final order. A De Novo classification decreases regulatory burdens. When FDA classifies a device type as class I or II via the De Novo pathway, other manufacturers do not have to submit a De Novo request or premarket approval application to market the same type of device, unless the device has a new intended use or technological characteristics that raise different questions of safety or effectiveness. Instead, manufacturers can use the less burdensome pathway of 510(k), when necessary, to market their device, and the device that was the subject of the original De Novo classification can serve as a predicate device for additional 510(k)s from other manufacturers. The device is assigned the generic name assayed quality control material for clinical microbiology assays, and it is identified as a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays. FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1: Table 1--Assayed Quality Control Material for Clinical Microbiology Assays Risks and Mitigation Measures ------------------------------------------------------------------------ Identified risks to health Required mitigations ------------------------------------------------------------------------ Incorrect use of the instrument for Special Control (1) (21 CFR non-indicated samples resulting in a 866.3920(b)(1)); Special delay in diagnosis. Control (3) (21 CFR 866.3920(b)(3)); and Special Control (4) (21 CFR 866.3920(b)(4)). Assessment performance error (false Special Control (1) (21 CFR negative). 866.3920(b)(1)). Incorrect results due to improper or Special Control (2) (21 CFR unexpected performance. 866.3920(b)(2)) and Special Control (4)(iii) (21 CFR 866.3920(b)(4)(iii)). Failure to correctly operate the Special Control (1) (21 CFR instrument. 866.3920(b)(1)). ------------------------------------------------------------------------ FDA believes that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. This device type is not exempt from premarket notification [[Page 34850]] requirements. Persons who intend to market this type of device must submit to FDA a premarket notification (510(k)), prior to marketing the device, which contains information about the assayed quality control material for clinical microbiology assays they intend to market. II. Analysis of Environmental Impact We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Paperwork Reduction Act of 1995 This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 866 Biologics, Laboratories, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for part 866 is revised to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. Add Sec. 866.3920 to subpart D to read as follows: Sec. 866.3920 Assayed quality control material for clinical microbiology assays. (a) Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays. (b) Classification. Class II (special controls). The special controls for this device are: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; (ii) Expected values; (iii) Analyte source; (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays; (C) Stating if the material is a surrogate control; and (D) The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: ``This product is not intended to replace manufacturer controls provided with the device.'' (iii) A limiting statement that reads ``Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.'' Dated: July 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15858 Filed 7-26-17; 8:45 am] BILLING CODE 4164-01-P
![34848 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
Jetstream Model 3201 airplanes, all serial ATTN: Doug Rudolph, Aerospace Engineer, support/support/aircraft-technical-
numbers, certificated in any category. FAA, Small Airplane Directorate, 901 Locust, publications/. For Heroux Devtek service
Room 301, Kansas City, Missouri 64106; information identified in this proposed AD,
(d) Subject telephone: (816) 329–4059; fax: (816) 329– contact Heroux Devtek Product Support, Unit
Air Transport Association of America 4090; email: doug.rudolph@faa.gov. Before 1, Pembroke Court, Chancellor Road, Manor
(ATA) Code 32: Landing Gear. using any approved AMOC on any airplane Park, Runcorn, Cheshire, WA7 1TG, England;
to which the AMOC applies, notify your phone: +44 01928 530530; fax: +44 01928
(e) Reason 579454; email: technical_support@
appropriate principal inspector (PI) in the
This AD was prompted by mandatory FAA Flight Standards District Office (FSDO), herouxdevtek.com; Internet: http://
continuing airworthiness information (MCAI) or lacking a PI, your local FSDO. www.herouxdevtek.com/aog-product-
originated by an aviation authority of another (2) Airworthy Product: For any requirement support.
country to identify and correct an unsafe in this AD to obtain corrective actions from (4) You may review copies of the
condition on an aviation product. The MCAI a manufacturer or other source, use these referenced service information at the FAA,
describes the unsafe condition as cracks in actions if they are FAA-approved. Corrective Small Airplane Directorate, 901 Locust,
the main landing gear (MLG) fitting at the actions are considered FAA-approved if they Kansas City, Missouri 64106. For information
pintle to cylinder interface, which could are approved by the State of Design Authority on the availability of this material at the
cause failure of the MLG during takeoff and (or their delegated agent). You are required FAA, call (816) 329–4148. In addition, you
landing. We are issuing this AD to detect and to assure the product is airworthy before it can access this service information on the
correct cracks in the main landing gear is returned to service. Internet at http://www.regulations.gov by
(MLG), which could lead to structural failure (3) Reporting Requirements: For any searching for and locating Docket No. FAA–
of the MLG and could result in loss of control reporting requirement in this AD, a federal 2017–0395.
during takeoffs and landings. (5) You may view this service information
agency may not conduct or sponsor, and a
that is incorporated by reference at the
(f) Actions and Compliance person is not required to respond to, nor
National Archives and Records
shall a person be subject to a penalty for
Unless already done, do the following Administration (NARA). For information on
actions listed in paragraphs (f)(1) through (3) failure to comply with a collection of
the availability of this material at NARA, call
of this AD: information subject to the requirements of 202–741–6030, or go to: http://
(1) Within the compliance times listed in the Paperwork Reduction Act unless that www.archives.gov/federal-register/cfr/ibr-
paragraph (f)(1)(i) or (ii) of this AD, as collection of information displays a current locations.html.
applicable, inspect the MLG for cracks valid OMB Control Number. The OMB
Control Number for this information Issued in Kansas City, Missouri, on July 12,
following Appendix 1 of British Aerospace 2017.
Jetstream Series 3100 and 3200 Service collection is 2120–0056. Public reporting for
Bulletin 32–JA960142, Revision No. 4, this collection of information is estimated to Pat Mullen,
October 21, 2016; or Heroux Devtek Service be approximately 5 minutes per response, Acting Manager, Small Airplane Directorate,
Bulletin 32–56, Revision 4, dated August 16, including the time for reviewing instructions, Aircraft Certification Service.
2016, as specified in British Aerospace completing and reviewing the collection of [FR Doc. 2017–15224 Filed 7–26–17; 8:45 am]
Jetstream Series 3100 and 3200 Service information. All responses to this collection
BILLING CODE 4910–13–P
Bulletin 32–JA960142, Revision No. 4, of information are mandatory. Comments
October 21, 2016. concerning the accuracy of this burden and
(i) For airplanes that have been inspected suggestions for reducing the burden should
following AD 97–10–05: Do the initial be directed to the FAA at: 800 Independence DEPARTMENT OF HEALTH AND
inspection within 1,200 flight cycles (FC) Ave. SW., Washington, DC 20591, Attn: HUMAN SERVICES
after the last inspection required by AD 97– Information Collection Clearance Officer,
10–05 and repetitively thereafter at intervals AES–200. Food and Drug Administration
not to exceed 1,200 FC. (h) Related Information
(ii) For airplanes that have not been 21 CFR Part 866
inspected following AD 97–10–05: Do the Refer to MCAI European Aviation Safety
initial inspection within 8,000 FC after Agency (EASA) AD 2017–0053, dated March [Docket No. FDA–2017–N–1917]
installation of the MLG or within the next 24, 2017. The MCAI can be found in the AD
100 FC after August 31, 2017 (the effective docket on the Internet at: https:// Medical Devices; Immunology and
date of this AD), whichever occurs later, and www.regulations.gov/document?D=FAA- Microbiology Devices; Classification of
repetitively thereafter at intervals not to 2017-0395-0002. the Assayed Quality Control Material
exceed 1,200 FC. (i) Material Incorporated by Reference for Clinical Microbiology Assays
(2) If any cracks are found during any of
the inspections required in paragraph (f)(1) of (1) The Director of the Federal Register AGENCY: Food and Drug Administration,
this AD, before further flight, replace the approved the incorporation by reference HHS.
MLG with an airworthy part following British (IBR) of the service information listed in this ACTION: Final order.
Aerospace Jetstream Series 3100 and 3200 paragraph under 5 U.S.C. 552(a) and 1 CFR
Service Bulletin 32–JA960142, Revision part 51. SUMMARY: The Food and Drug
No. 4, October 21, 2016. (2) You must use this service information Administration (FDA, Agency, or we) is
(3) The compliance times in paragraphs as applicable to do the actions required by
classifying the assayed quality control
(f)(1)(i) and (ii) of this AD are presented in this AD, unless the AD specifies otherwise.
(i) British Aerospace Jetstream Series 3100
material for clinical microbiology assays
FC (landings). If the total FC have not been into class II (special controls). The
kept, multiply the total number of airplane and 3200 Service Bulletin 32–JA960142,
hours time-in-service (TIS) by 0.75 to Revision No. 4, October 21, 2016. special controls that will apply to the
calculate the FC. For the purposes of this AD: (ii) Heroux Devtek Service Bulletin 32–56, device are identified in this order and
(i) 100 hours TIS × .75 = 75 FC; and Revision 4, dated August 16, 2016. will be part of the codified language for
(ii) 1,000 hours TIS × .75 = 750 FC. (3) For British Aerospace Jetstream Series the assayed quality control material for
3100 and 3200 service information related to clinical microbiology assays’
(g) Other FAA AD Provisions this AD, contact BAE Systems (Operations)
mstockstill on DSK30JT082PROD with RULES
classification. The Agency is classifying
The following provisions also apply to this Ltd, Business Support Team-Technical the device into class II (special controls)
AD: Publications, Prestwick International Airport,
to provide a reasonable assurance of
(1) Alternative Methods of Compliance Ayrshire, KA9 2RW, Scotland, United
(AMOCs): The Manager, Standards Office, Kingdom; phone: +44 1292 675207; fax: +44 safety and effectiveness of the device.
FAA, has the authority to approve AMOCs 1292 675704; email: RApublications@ DATES: This order is effective July 27,
for this AD, if requested using the procedures baesystems.com; Internet: https:// 2017. The classification was applicable
found in 14 CFR 39.19. Send information to www.regional-services.com/spares_and_ on March 28, 2016.
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![34850 Federal Register / Vol. 82, No. 143 / Thursday, July 27, 2017 / Rules and Regulations
requirements. Persons who intend to use with either qualitative or statement: ‘‘This product is not
market this type of device must submit quantitative assays. intended to replace manufacturer
to FDA a premarket notification (b) Classification. Class II (special controls provided with the device.’’
(510(k)), prior to marketing the device, controls). The special controls for this (iii) A limiting statement that reads
which contains information about the device are: ‘‘Quality control materials should be
assayed quality control material for (1) Premarket notification used in accordance with local, state,
clinical microbiology assays they intend submissions must include detailed federal regulations, and accreditation
to market. device description documentation and requirements.’’
information concerning the composition Dated: July 24, 2017.
II. Analysis of Environmental Impact of the quality control material, Anna K. Abram,
We have determined under 21 CFR including, as appropriate:
25.34(b) that this action is of a type that Deputy Commissioner for Policy, Planning,
(i) Analyte concentration;
Legislation, and Analysis.
does not individually or cumulatively (ii) Expected values;
have a significant effect on the human (iii) Analyte source; [FR Doc. 2017–15858 Filed 7–26–17; 8:45 am]
environment. Therefore, neither an (iv) Base matrix; BILLING CODE 4164–01–P
environmental assessment nor an (v) Added components;
environmental impact statement is (vi) Safety and handling information;
required. and DEPARTMENT OF HEALTH AND
(vii) Detailed instructions for use. HUMAN SERVICES
III. Paperwork Reduction Act of 1995 (2) Premarket notification
This final order establishes special submissions must include detailed Food and Drug Administration
controls that refer to previously documentation, including line data as
approved collections of information well as detailed study protocols and a 21 CFR Part 870
found in other FDA regulations. These statistical analysis plan used to establish [Docket No. FDA–2017–N–1916]
collections of information are subject to performance, including:
review by the Office of Management and (i) Description of the process for value Medical Devices; Cardiovascular
Budget (OMB) under the Paperwork assignment and validation. Devices; Classification of the Balloon
Reduction Act of 1995 (44 U.S.C. 3501– (ii) Description of the protocol(s) used Aortic Valvuloplasty Catheter
3520). The collections of information in to establish stability. AGENCY: Food and Drug Administration,
part 807, subpart E, regarding premarket (iii) Line data establishing precision/
HHS.
notification submissions have been reproducibility.
(iv) Where applicable, assessment of ACTION: Final order.
approved under OMB control number
0910–0120, and the collections of matrix effects and any significant SUMMARY: The Food and Drug
information in 21 CFR parts 801 and differences between the quality control Administration (FDA, Agency, or we) is
809, regarding labeling have been material and typical patient samples in classifying the balloon aortic
approved under OMB control number terms of conditions known to cause valvuloplasty catheter into class II
0910–0485. analytical error or affect assay (special controls). The special controls
performance. that will apply to the device are
List of Subjects in 21 CFR Part 866 (v) Where applicable, identify or identified in this order and will be part
Biologics, Laboratories, Medical define traceability or relationship to a of the codified language for the balloon
devices. domestic or international standard aortic valvuloplasty catheter’s
Therefore, under the Federal Food, reference material and/or method. classification. The Agency is classifying
Drug, and Cosmetic Act and under (vi) Where applicable, detailed the device into class II (special controls)
authority delegated to the Commissioner documentation related to studies for to provide a reasonable assurance of
of Food and Drugs, 21 CFR part 866 is surrogate controls. safety and effectiveness of the device.
amended as follows: (3) Premarket notification
DATES: This order is effective July 27,
submissions must include an adequate
PART 866—IMMUNOLOGY AND mitigation (e.g., real-time stability 2017. The classification was applicable
MICROBIOLOGY DEVICES program) to the risk of false results due on June 11, 2012.
to potential modifications to the assays FOR FURTHER INFORMATION CONTACT:
■ 1. The authority citation for part 866 specified in the device’s 21 CFR 809.10 Nicole Ibrahim, Center for Devices and
is revised to read as follows: compliant labeling. Radiological Health, Food and Drug
Authority: 21 U.S.C. 351, 360, 360c, 360e, (4) Your 21 CFR 809.10 compliant Administration, 10903 New Hampshire
360j, 360l, 371. labeling must include the following: Ave., Bldg. 66, Rm. 1232, Silver Spring,
■ 2. Add § 866.3920 to subpart D to read (i) The intended use of your 21 CFR MD, 20993–0002, 301–796–5171,
as follows: 809.10(a)(2) and (b)(2) compliant nicole.ibrahim@fda.hhs.gov.
labeling must include the following: SUPPLEMENTARY INFORMATION:
§ 866.3920 Assayed quality control (A) Assayed control material
material for clinical microbiology assays. I. Background
analyte(s);
(a) Identification. An assayed quality (B) Whether the material is intended In accordance with section 513(f)(1) of
control material for clinical for quantitative or qualitative assays; the Federal Food, Drug, and Cosmetic
microbiology assays is a device (C) Stating if the material is a Act (the FD&C Act) (21 U.S.C.
mstockstill on DSK30JT082PROD with RULES
indicated for use in a test system to surrogate control; and 360c(f)(1)), devices that were not in
estimate test precision or to detect (D) The system(s), instrument(s), or commercial distribution before May 28,
systematic analytical deviations that test(s) for which the quality control 1976 (the date of enactment of the
may arise from reagent or analytical material is intended. Medical Device Amendments of 1976),
instrument variation. This type of (ii) The intended use in your 21 CFR generally referred to as postamendments
device consists of single or multiple 809.10(a)(2) and (b)(2) compliant devices, are classified automatically by
microbiological analytes intended for labeling must include the following statute into class III without any FDA
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Document Created: 2017-07-27 02:07:10
Document Modified: 2017-07-27 02:07:10
| 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 | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective July 27, 2017. The classification was applicable on March 28, 2016. | |
| Contact | Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4545, Silver Spring, MD 20993-0002, 240-402-6357, [email protected] | |
| FR Citation | 82 FR 34848 | |
| CFR Associated | Biologics; Laboratories and Medical Devices |
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