83 FR 25910 - Medical Devices; Exemptions From Premarket Notification: Class II Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 108 (June 5, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 108 (June 5, 2018)
| Page Range | 25910-25915 | |
| FR Document | 2018-11879 |
[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)] [Rules and Regulations] [Pages 25910-25915] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11879] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 862, 866, 876, 880, and 884 [Docket No. FDA-2017-N-1129] Medical Devices; Exemptions From Premarket Notification: Class II Devices AGENCY: Food and Drug Administration, HHS. ACTION: Final order. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k). DATES: This order is effective June 5, 2018. FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices and [[Page 25911]] Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 4676, Silver Spring, MD 20993-0002, 301- 796-6217. SUPPLEMENTARY INFORMATION: I. Statutory Background Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, 21 CFR part 807, subpart E, require persons who intend to market a new device to submit and obtain clearance of a premarket notification (510(k)) 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 (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval. On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(2) provides that, 1 calendar day after the date of publication of the final list under section 510(1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act, upon its own initiative or a petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and provide a 60-calendar-day comment period. Within 120 days of publication of such notice, FDA shall publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice. 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 January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 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'' (``Class II 510(k) Exemption Guidance''). That guidance can be obtained through the internet at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf or by sending an email request to [email protected] to receive a copy of the document. Please use the document number 159 to identify the guidance you are requesting. Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary for class II devices: (1) The device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions. III. Comments on the Proposed Exemption and FDA Response In the Federal Register of November 7, 2017 (82 FR 51633), FDA published a notice (``November 2017 notice'') announcing its intent to exempt, upon its own initiative, certain class II devices listed in table 1 from 510(k) requirements, subject to certain limitations, and provided opportunity for interested persons to submit comments by January 8, 2018. After reviewing comments received, FDA is now providing its final determination on exempting the certain class II devices listed in table 1 from 510(k) requirements, subject to certain limitations as identified in this order. FDA is also amending the codified language for the classification regulations for the certain class II devices listed in table 1 to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from 510(k), subject to the limitations, should withdraw their submissions. In response to the November 2017 notice announcing FDA's intent to exempt those device types from 510(k) requirements, FDA received a submission from one commenter--a professional organization--opposing an exemption from 510(k) for the genetic health risk assessment test device type. To make it easier to identify comments and our responses, the word ``Comment'' appears in parentheses before the comment's description, and the word ``Response'' in parentheses precedes the response. Specific issues raised by the comment and the Agency's response follows. (Comment) The commenter recommended FDA not exempt one-time FDA reviewed genetic health risk assessment system devices from the 510(k) requirement because there would be insufficient oversight to ensure the analytical and clinical validity of these tests, consumers would be misled regarding which tests FDA has affirmed are scientifically valid, and concerns that, if one-time FDA reviewed genetic health risk assessment system devices were exempted, consumers would not be assured of being adequately informed about test quality. The commenter believed it is not possible to assess the analytical and clinical validity of all genetic health risks a company might offer by conducting a one-time review of its `assessment system', as proposed by FDA. Such oversight, it is argued, will only allow FDA to assess the analytical and clinical validity, and `mitigate the risks of false negatives and positives', for tests initially proposed by the company during this one-time review. The commenter believed that it does not appear that there will be assessment of the analytical or clinical validity of subsequent tests offered, nor any assessment of the risks to the consumer of an incorrect result. This commenter believed that FDA's proposal to exempt one-time FDA reviewed genetic health risk assessment system devices will not prevent scientifically invalid tests from being marketed to the public and lacks a comprehensive assessment. Further, the commenter argued that, after undergoing the one-time FDA review for genetic health risk assessment tests, companies would be able to market subsequent tests to the public as part of the same system and declare that the tests meet FDA's standards. Such tests would not be held to any specific standards of analytical or clinical validity. The public would likely assume (and purveyors would likely advertise) that FDA had reviewed and approved such tests as valid even though they had not been reviewed by the Agency. The commenter also argued that there is a vast range of quality (i.e., scientific merit) of direct-to-consumer (DTC) genetic health risk assessment tests on the market. The commenter argued that the market's current mixing of entertainment tests, which make claims unsubstantiated by the scientific literature, with those tests which have a clinical utility, are clinically valid, and can be supported by current scientific [[Page 25912]] literature, is particularly confusing for the average consumer. (Response) We agree that the concerns raised above are important. These concerns were considered during our review and development of the initial classification regulation for genetic health risk assessment system devices and in our consideration of whether to exempt one-time FDA reviewed genetic health risk assessment system devices from the 510(k) requirement. We believe these concerns have been addressed and accounted for in our determination that the 510(k) requirement is not necessary to provide a reasonable assurance of safety and effectiveness for these devices. We outline our rationale below. Consumer understanding of genetic risk is clearly an important issue that was considered extensively by FDA in the context of genetic health risk assessment system devices. This issue was balanced with the increasing desire from the public to learn more about one's own genetic makeup and how it affects genetic risk for health conditions. To ensure that the tests and test reports are presented to the lay consumer in a manner that is understandable, we employed several requirements. Consumer understanding of the tests and associated test reports is assured by user comprehension study requirements, specific labeling requirements for these over-the-counter (OTC) tests, and general requirements for devices. The special labeling requirements for these devices under Sec. 866.5950(b) (21 CFR 866.5950(b)) include providing information on the manufacturer's website about frequently asked questions, available professional guidelines, and how to obtain access to a genetic counselor. A. User Comprehension Study A user comprehension study is required under Sec. 866.5950(b)(3)(iii)(M). The required user comprehension study must assess comprehension of the test process and results by potential users of the test with pre- and post-test user comprehension studies. This study must be conducted on a statistically sufficient sample size of non-trained individuals who represent the demographics of the United States as well as a diverse range of age and educational levels. The study must include directly evaluating a representative sample of the material being presented to the user during use of the test. The test that is given to the participants must be informed by a physician and/ or genetic counselor that identifies the appropriate general and variant-specific concepts contained within the material being tested in the user comprehension study to ensure that all relevant concepts are incorporated in the study as well as having included the definition of the target condition being tested and related symptoms, explain the intended use and limitations of the test, explain the relevant ethnicities in regard to the variant tested, explain genetic health risks and relevance to the user's ethnicity, and assess participants' ability to understand the following comprehension concepts: The test's limitations, purpose, appropriate action, test results, and other factors that may have an impact on the test results. The outcome of this study has to meet rigorous standards, including meeting predefined primary endpoint criteria, including a minimum of a 90 percent or greater overall comprehension rate (i.e., selection of the correct answer) for each comprehension concept. In addition, the testing must follow a format where users have limited time to complete the studies (such as an onsite survey format and a one-time visit with a cap on the maximum amount of time that a participant has to complete the tests). From our experience with user comprehension studies, the Agency believes that meeting or exceeding these user comprehension study requirements ensures that the materials presented to the user are adequate for OTC use. The information the test provider must provide on its website includes a summary table of comprehension rates regarding comprehension concepts (e.g., purpose of test, test results, test limitations, ethnicity relevance for the test results, etc.) for each study report. B. Frequently Asked Questions The manufacturer's website must have a frequently asked questions section in the summary and technical information sections under Sec. 866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). For the frequently asked questions sections, information must be included that is specific for each variant/disease pair that is reported and scientifically valid and supported by corresponding publications. Further information must be included that explains the health condition/disease being tested, the purpose of the test, the information the test will and will not provide, the relevance of race and ethnicity on the test results, information about the population to which the variants in the test is most applicable, the meaning of the result(s), other risks factors that contribute to disease, appropriate followup procedures, how the results of the test may affect the user's family, including children, and links to resources that provide additional information. C. Resources Likely the test labeling information provided by the test manufacturer will not be the sole source of information that the consumer is seeking or even requires. For this reason, there are requirements under Sec. 866.5950(b)(3)(ii)(C)(2) and (b)(3)(iii)(L)(2) that the manufacturer of the test provide a pre-purchase page in the summary and technical information sections that includes information regarding professional guidelines for testing specific genes and variants. Similar information must be provided in the frequently asked questions section found in the summary and technical information sections on the manufacturer's website, under Sec. 866.5950(b)(3)(ii)(C)(3) and (b)(3)(iii)(L)(3). These frequently asked questions sections must include a statement about the current professional guidelines for testing these specific gene(s) and variant(s) and, if guidelines do not exist for certain genes or variants being tested for, then this information must be provided as well. Further, to facilitate more personalized support, under Sec. 866.5950(b)(1)(i)(E), test manufacturers are required to provide information in the Sec. 809.10 (21 CFR 809.10) compliant labeling and any pre-purchase page and test report generated regarding how a user obtains access to a genetic counselor, board-certified clinical molecular geneticist, or equivalent healthcare professional regarding the results of a user's test. D. Genetic Health Risk Assessment System Tests The tests that fall under the genetic health risk assessment system regulation are identified in the regulation in Sec. 866.5950(a) as a qualitative in vitro molecular diagnostic system used for detecting variants in genomic deoxyribonucleic acid (DNA) isolated from human specimens that will provide information to users about their genetic risk of developing a disease to inform lifestyle choices and/or conversations with a healthcare professional. This assessment system is for OTC use. This device does not determine the person's overall risk of developing a disease. The limitations that are most important for lay users to know about the intended use of these tests that fall under this device type are conveyed via the limiting statements required, under Sec. 866.5950(b)(1)(i), to be provided on the Sec. 809.10 compliant labeling and any pre-purchase page and test report generated. One of these limiting statements must explain that this test is [[Page 25913]] not intended to diagnose a disease, tell you anything about your current state of health, or be used to make medical decisions, including whether or not you should take a medication or how much of a medication you should take. The limitations that are most important for healthcare professionals to know about the intended use of tests that fall under this device type are, under Sec. 866.5950(b)(1)(ii), required to be provided in the Sec. 809.10 labeling and any test report generated. These limitations include that the test is intended to provide users with their genetic information to inform lifestyle decisions and conversations with their doctor or other healthcare professional and that any diagnostic or treatment decisions should be based on testing and/or other information that a healthcare professional determines to be appropriate for a patient. E. Rigorous Validation Requirements FDA believes the analytical validation requirements are sufficiently detailed in the special controls under Sec. 866.5950(b)(3)(iii)(J) that test providers will have no difficulty in appropriately following these requirements. A high accuracy requirement is necessary for tests that are provided under this regulation and accuracy point estimates for all variants is required to be 99 percent or higher under Sec. 866.5950(b)(3)(iii)(J)(1)(vii) or else they cannot be claimed or reported. Once FDA has reviewed one test that demonstrates this level of accuracy, then the test provider has demonstrated an ability to meet the accuracy requirements for additional similar tests offered. F. Four Important Limitations on the Scope of the Classification Regulation FDA agrees that there are four important express limitations to the types of tests that can be offered under this classification regulation even when these special controls are met. Tests cannot be offered under this classification regulation that are indicated for prenatal testing; predisposition for cancer where the result of the test may lead to prophylactic screening, confirmatory procedures, or treatments that may incur morbidity or mortality to the patient; assessing the presence of genetic variants that impact the metabolism, exposure, response, risk of adverse events, dosing, or mechanisms of prescription or OTC medications; or assessing the presence of deterministic autosomal dominant variants. G. False or Misleading Claims It is a prohibited act for devices to have labeling that is false or misleading in any particular manner, and thus FDA would deem such device to be misbranded under section 502(a) of the FD&C Act (21 U.S.C. 352(a)). This prohibition would include prohibiting the manufacturer of a genetic health risk assessment test device from falsely or misleadingly representing a test as having been part of an original FDA cleared device when it was added subsequently to FDA clearance. This prohibition would also include falsely or misleadingly representing the analytical or clinical validity of one of its tests. In addition, under section 502(c) of the FD&C Act, it is a prohibited act and thus FDA would deem a device to be misbranded if any information required on the labeling of a device by FDA by or under the FD&C Act is not placed prominently thereon with such conspicuousness and in such terms, as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Thus, a genetic health risk assessment test device for which a manufacturer later modified the formerly compliant labeling to make the labeling such that the labeling was not likely to be read and understood by the ordinary individual under customary conditions of purchase and use would be a misbranded device. H. Conclusion In summary, all tests that are marketed under this classification regulation must meet the general controls and the special controls that are specified in the regulation. Ability of a manufacturer to meet these special controls is demonstrated during the one-time review. Even after the one-time review, the general controls and special controls must continue to be met, including for all tests added or modified after the one-time review of a manufacturer's device. IV. Limitations on Exemptions FDA has determined that 510(k) is not necessary to assure the safety and effectiveness of the class II devices listed in table 1. This determination is based, in part, on the Agency's knowledge of the device, including past experience and relevant reports or studies on device performance (as appropriate), the applicability of general and special controls, and the Agency's ability to limit an exemption. A. General Limitations of Exemptions FDA's exemption from 510(k) for class II devices listed in table 1 applies only to those devices that have existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type, or, in the case of in vitro diagnostic devices, for which a misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. A manufacturer of a listed device is still required to submit a 510(k) to FDA before introducing a device or delivering it for introduction into commercial distribution when the device meets any of the conditions described in Sec. Sec. 862.9 to 892.9 (21 CFR 862.9 to 21 CFR 892.9). B. Partial Limitations of Exemptions In addition to the general limitations, FDA may also partially limit an exemption from 510(k) requirements to specific devices within a listed device type when initial Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance do not weigh in favor of exemption for all devices in a particular group. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. In table 1, for example, FDA is listing the exemption of the genetic health risk assessment system, but limits the exemption to such devices that have received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a ``one-time FDA reviewed genetic health risk assessment system''). FDA has determined that a one-time FDA review (e.g., premarket notification) of a genetic health risk assessment system is necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that a one-time FDA review of a genetic health risk assessment system is necessary to mitigate the risk of false negatives and false positives by ensuring that certain information be submitted to FDA to allow the Agency to assess the safety and effectiveness of the devices as well as to ensure the devices perform to acceptable standards. Exemption from the requirement of 510(k) does not exempt a device from other applicable regulatory controls under the FD&C Act, including the applicable general and special controls. This exemption from 510(k), subject to the limitations described above, is immediately in effect for the device types identified in table 1. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and [[Page 25914]] expenditures required to comply with Federal regulations. V. List of Class II Devices FDA is identifying the following list of class II devices that will 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 and any partial exemption limitations identified in table 1: Table 1--Class II Devices ---------------------------------------------------------------------------------------------------------------- Partial exemption 21 CFR section Device type Product code limitation (if applicable) ---------------------------------------------------------------------------------------------------------------- 862.1840............................ Total 25-hydroxyvitamin PSL ........................... D Mass Spectrometry Test System. 866.5950............................ Genetic Health Risk PTA Exemption is limited to a Assessment System. genetic health risk assessment system that has received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a ``one-time FDA reviewed genetic health risk assessment system''). 876.1500............................ Endoscope Disinfectant PUP ........................... Basin. 880.6710............................ Purifier, Water, KMG ........................... Ultraviolet, Medical. 884.5960............................ Vibrator for KXQ ........................... Therapeutic Use, Genital. ---------------------------------------------------------------------------------------------------------------- FDA is revising the name of product code PUP to further clarify the device type that this product code is intended to represent. The device type was previously ``Endoscope Maintenance System.'' To more accurately reflect the devices which fall within this device type (product code PUP), the device type has been renamed ``Endoscope Disinfectant Basin.'' Specifically, these devices are described as ``Wall-mounted tube(s) for holding disinfectant solution and endoscope insertion tubes and accessories.'' This description has not changed since publication of the November 2017 notice. VI. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.30(h) 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. VII. Paperwork Reduction Act of 1995 This final order refers to previously approved collections of information found in other FDA regulations and guidance. 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 21 CFR Part 862 Medical devices. 21 CFR Part 866 Biologics, Laboratories, Medical devices. 21 CFR Parts 876, 880, and 884 Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 862, 866, 876, 880, and 884 are amended as follows: PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 0 1. The authority citation for part 862 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 2. In Sec. 862.1840, revise paragraph (b) introductory text to read as follows: Sec. 862.1840 Total 25-hydroxyvitamin D mass spectrometry test system. * * * * * (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in Sec. 862.9. The device must comply with the following special controls: * * * * * PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 3. The authority citation for part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 4. In Sec. 866.5950, revise paragraph (b) introductory text to read as follows: Sec. 866.5950 Genetic health risk assessment system. * * * * * (b) Classification. Class II (special controls). The genetic health risk assessment system device, when it has previously received a first- time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a ``one-time FDA reviewed genetic health risk assessment system''), is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in Sec. 866.9. The device must comply with the following special controls: * * * * * PART 876--GASTROENTEROLOGY-UROLOGY DEVICES 0 5. The authority citation for part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 6. In Sec. 876.1500, revise paragraph (b)(1) to read as follows: Sec. 876.1500 Endoscope and accessories. * * * * * (b) * * * (1) Class II (performance standards). The device, when intended as an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories, is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in Sec. 876.9. * * * * * [[Page 25915]] PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES 0 7. The authority citation for part 880 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 8. In Sec. 880.6710, revise paragraph (b) to read as follows: Sec. 880.6710 Medical ultraviolet water purifier. * * * * * (b) Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in Sec. 880.9. PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES 0 9. The authority citation for part 884 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 0 10 In Sec. 884.5960, revise paragraph (b) to read as follows: Sec. 884.5960 Genital vibrator for therapeutic use. * * * * * (b) Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in Sec. 884.9. Dated: May 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-11879 Filed 6-1-18; 8:45 am] BILLING CODE 4164-01-P
![25910 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations
number of small entities under the Auburn, CA, Auburn Muni, RNAV (GPS) Tiffin, OH, Seneca County, RNAV (GPS)
criteria of the Regulatory Flexibility Act. RWY 7, Orig-B RWY 24, Amdt 1C
Long Beach, CA, Long Beach/Daugherty Tiffin, OH, Seneca County, VOR RWY 6,
List of Subjects in 14 CFR Part 97 Field/, ILS OR LOC RWY 30, Amdt 34 Amdt 9B
Long Beach, CA, Long Beach/Daugherty Anderson, SC, Anderson Rgnl, RNAV (GPS)
Air traffic control, Airports, Field/, RNAV (RNP) RWY 26R, Amdt 1A RWY 23, Amdt 2
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2018. Long Beach, CA, Long Beach/Daugherty Eastsound, WA, Orcas Island, RNAV (GPS)
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John S. Duncan, Oakland, CA, Metropolitan Oakland Intl, Port Angeles, WA, William R Fairchild Intl,
Executive Director, Flight Standards Service. RNAV (RNP) Z RWY 12, Amdt 2 ILS OR LOC RWY 8, Amdt 3A
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authority delegated to me, Title 14, VOR RWY 30, Amdt 2 RNAV (GPS) RWY 26, Amdt 1B
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establishing, amending, suspending, or Intl, ILS OR LOC RWY 16, ILS RWY 16 SA Port Angeles, WA, William R Fairchild Intl,
removing Standard Instrument CAT I, ILS RWY 16 SA CAT II, Amdt 3 WATTR SEVEN, Graphic DP
Approach Procedures and/or Takeoff Douglas, GA, Douglas Muni, ILS OR LOC New Holstein, WI, New Holstein Muni,
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Procedures effective at 0901 UTC on the Kahului, HI, Kahului, ILS OR LOC RWY 2, [FR Doc. 2018–11836 Filed 6–4–18; 8:45 am]
dates specified, as follows: Amdt 25A
BILLING CODE 4910–13–P
Springfield, IL, Abraham Lincoln Capital,
PART 97—STANDARD INSTRUMENT VOR RWY 4, Orig-C
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21 CFR Parts 862, 866, 876, 880, and
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follows: 1
Effective 21 June 2018 Sterling/Rockfalls, IL, Whiteside Co Arpt-Jos Medical Devices; Exemptions From
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Minimums and Obstacle DP, Amdt 6A Howell, MI, Livingston County Spencer J
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County, ILS OR LOC RWY 22L, ILS RWY CANCELED ACTION: Final order.
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Detroit, MI, Detroit Metropolitan Wayne SUMMARY: The Food and Drug
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County, RNAV (RNP) X RWY 21L, Orig-A (GPS) RWY 32, Amdt 1C exemption from 510(k), subject to
St Paul, MN, St Paul Downtown Holman Fld, Menominee, MI, Menominee Rgnl, Takeoff certain limitations, is immediately in
ILS OR LOC RWY 32, Amdt 6A Minimums and Obstacle DP, Amdt 3A
Omaha, NE, Eppley Airfield, RNAV (GPS) Y
effect for the listed class II devices. This
Menominee, MI, Menominee Rgnl, VOR–A,
RWY 18, Amdt 4A Amdt 3C
exemption will decrease regulatory
Saranac Lake, NY, Adirondack Rgnl, Takeoff Cabool, MO, Cabool Memorial, RNAV (GPS) burdens on the medical device industry
Minimums and Obstacle DP, Amdt 8 RWY 21, Orig-B and will eliminate private costs and
Cleveland, OH, Cleveland-Hopkins Intl, Cabool, MO, Cabool Memorial, VOR/DME expenditures required to comply with
RNAV (GPS) Y RWY 6L, Amdt 2A RWY 21, Amdt 2A, CANCELED certain Federal regulations. FDA is also
Ottawa, OH, Putnam County, VOR RWY 27, Ithaca, NY, Ithaca Tompkins Rgnl, ILS OR amending the codified language for the
Amdt 2C LOC RWY 32, Amdt 7 listed class II devices to reflect this final
Ithaca, NY, Ithaca Tompkins Rgnl, RNAV determination. FDA is publishing this
Effective 19 July 2018 (GPS) RWY 32, Orig-B
Manley Hot Springs, AK, Manley Hot Ithaca, NY, Ithaca Tompkins Rgnl, VOR RWY
order in accordance with the section of
Springs, RNAV (GPS) RWY 18, Orig 14, Amdt 14A, CANCELED the Federal Food, Drug, and Cosmetic
Manley Hot Springs, AK, Manley Hot Ogdensburg, NY, Ogdensburg Intl, RNAV Act (FD&C Act) permitting the
amozie on DSK3GDR082PROD with RULES
Springs, RNAV (GPS) RWY 36, Orig (GPS) RWY 9, Amdt 1 exemption of a device from the
Manley Hot Springs, AK, Manley Hot Watertown, NY, Watertown Intl, Takeoff requirement to submit a 510(k).
Springs, Takeoff Minimums and Obstacle Minimums and Obstacle DP, Amdt 3 DATES: This order is effective June 5,
DP, Orig Tiffin, OH, Seneca County, NDB RWY 24, 2018.
Fayetteville/Springdale/Rogers, AR, Amdt 7D
Northwest Arkansas Rgnl, ILS OR LOC Tiffin, OH, Seneca County, RNAV (GPS) FOR FURTHER INFORMATION CONTACT:
RWY 34, Amdt 4 RWY 6, Orig-B Scott McFarland, Center for Devices and
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![Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations 25915
PART 880—GENERAL HOSPITAL AND to veterans who are at risk of becoming 61.90 Grant for Case Management
PERSONAL USE DEVICES homeless. The grant program Services—Program
established by this interim final rule Paragraph (a) of § 61.90 states that
■ 7. The authority citation for part 880 will be an essential part of VA’s non-profit organizations and State,
continues to read as follows: attempts to eliminate homelessness local, and tribal governments are
Authority: 21 U.S.C. 351, 360, 360c, 360e, among the veteran population. eligible to apply for a grant to provide
360j, 360l, 371. DATES: This final rule is effective June case management services. (For
5, 2018. Comments must be received on purposes of this program, the term
■ 8. In § 880.6710, revise paragraph (b)
or before August 6, 2018. ‘‘tribal government’’ means an entity
to read as follows:
ADDRESSES: Written comments may be described in paragraph (2) of the
§ 880.6710 Medical ultraviolet water submitted through http:// definition of public entity in 38 CFR
purifier. www.Regulations.gov; by mail or hand- 61.1.) To ensure that grant funding is
* * * * * delivery to: Director, Regulation Policy used to provide case management
(b) Classification. Class II and Management (00REG), Department services to as many veterans as possible,
(performance standards). The device is of Veterans Affairs, 810 Vermont Ave. this same paragraph provides that case
exempt from the premarket notification NW, Room 1063B, Washington, DC management services grant funds under
procedures in part 807, subpart E, of 20420; or by fax to (202) 273–9026. this program ‘‘may not be used for
this chapter subject to the limitations in (This is not a toll-free telephone veterans who are receiving case
§ 880.9. number.) Comments should indicate management services from permanent
that they are submitted in response to supportive housing programs (e.g.
PART 884—OBSTETRICAL AND ‘‘RIN 2900–AQ15—Case Management Housing and Urban Development-VA
GYNECOLOGICAL DEVICES Services Grant Program.’’ Copies of Supportive Housing) or rapid re-
comments received will be available for housing/homeless prevention programs
■ 9. The authority citation for part 884 public inspection in the Office of
continues to read as follows: (e.g. Supportive Services for Veterans
Regulation Policy and Management, Families (SSVF)).’’ Paragraph (b)
Authority: 21 U.S.C. 351, 360, 360c, 360e, Room 1063B, between the hours of 8 identifies examples of case management
360j, 360l, 371. a.m. and 4:30 p.m., Monday through services that grantees can provide using
■ 10 In § 884.5960, revise paragraph (b) Friday (except holidays). Please call these grant funds. Such services
to read as follows: (202) 461–4902 for an appointment. include, but are not limited to, ‘‘Making
(This is not a toll-free telephone home visits by the case manager to
§ 884.5960 Genital vibrator for therapeutic number.) In addition, during the monitor housing stability; Providing or
use. comment period, comments may be coordinating educational activities
* * * * * viewed online through the Federal related to meal planning, tenant
(b) Classification. Class II Docket Management System (FDMS) at responsibilities, the use of public
(performance standards). The device is http://www.Regulations.gov. transportation, community resources,
exempt from the premarket notification FOR FURTHER INFORMATION CONTACT: financial management, and the
procedures in part 807, subpart E, of Jeffery Quarles, Director, Grant and Per development of natural supports;
this chapter subject to the limitations in Diem Program, (10NC1HM), VA Making referrals to needed services,
§ 884.9. National Grant and Per Diem Program such as mental health, substance use
Dated: May 29, 2018. Office, 10770 N 46th Street, Suite C– disorder, medical, and employment
Leslie Kux, 200, Tampa, FL 33617, (877) 332–0334. services; and Participating in case
Associate Commissioner for Policy.
(This is a toll-free number.) conferencing with other service
SUPPLEMENTARY INFORMATION: In an providers who are working with the
[FR Doc. 2018–11879 Filed 6–1–18; 8:45 am]
effort to reduce homelessness in the veteran.’’ Paragraph (c) sets a 6-month
BILLING CODE 4164–01–P
veteran population, Congress has time limit for veterans to receive case
required VA to expand its benefits for management services. However, VA
homeless veterans by establishing a new may approve a request to extend
DEPARTMENT OF VETERANS grant program to provide funds to
AFFAIRS services beyond the 6-month period if
organizations within communities that an organization submits a request to VA
38 CFR Part 17 will provide case management services in writing and VA approves it before the
to improve the retention of housing by 6-month time limit expires. Because in
RIN 2900–AQ15 veterans who were previously homeless most circumstances case management
and are transitioning to permanent services are provided to veterans after
Case Management Services Grant housing and to veterans who are at risk they have been in receipt of benefits
Program of becoming homeless. See Public Law under the Grant and Per Diem Program,
AGENCY: Department of Veterans Affairs. 114–315, sec. 712 (Dec. 16, 2016) VA believes that 6 months would, in
ACTION: Interim final rule. (codified at 38 U.S.C. 2013). This most cases, be sufficient time for a
interim final rule adds this new case veteran to have the necessary tools in
SUMMARY: The Department of Veterans management program to VA’s Homeless place to retain permanent housing.
Affairs (VA) is amending its regulations Providers Grant and Per Diem Program
that govern programs benefitting regulations by adding a new subpart G 61.92 Grant for Case Management
homeless veterans to implement a new to 38 CFR part 61 to accurately reflect Services—Application and Rating
amozie on DSK3GDR082PROD with RULES
statutory requirement to establish a new these changes in law. The new case Criteria
grant program that will provide case management program will mirror For ease of administration and
management services to improve the existing homeless grant per diem internal consistency between grant
retention of housing by veterans who programs as much as possible for ease programs benefiting homeless veterans,
were previously homeless and are of administrating and running the new VA will, to the extent applicable and
transitioning to permanent housing and grant program. appropriate, adopt standards for the
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Document Created: 2018-11-02 11:47:24
Document Modified: 2018-11-02 11:47:24
| 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 June 5, 2018. | |
| Contact | Scott McFarland, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 4676, Silver Spring, MD 20993-0002, 301- 796-6217. | |
| FR Citation | 83 FR 25910 | |
| CFR Citation | 21
CFR
862 21 CFR 866 21 CFR 876 21 CFR 880 21 CFR 884 | |
| CFR Associated | Medical Devices; Biologics and Laboratories |
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