Unknown. Final amendment; final order

4,913 words·~22 min read·/register/2022/02/18/2022-03504·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2022-02-18.xml --- 87 34 Friday, February 18, 2022 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Request for Information: Proposed Patient-Centered Outcomes Research Trust Fund Strategic Framework, 9360-9362 2022-03551 Agriculture Agriculture Department See Farm Service Agency See Forest Service See The U.S. Codex Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 9307-9308 2022-03594 Alcohol Tobacco Tax Alcohol and Tobacco Tax and Trade Bureau NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9420-9423 2022-03569 Census Bureau Census Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Population Survey, School Enrollment Supplement, 9311-9312 2022-03588 Meetings: Census Scientific Advisory Committee, 9311 2022-03488 National Advisory Committee, 9312-9313 2022-03548 Centers Disease Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 9362 2022-03554 2022-03555 Children Children and Families Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Low Income Household Water Assistance Program Reports, 9364-9365 2022-03610 Regional Partnership Grants National Cross-Site Evaluation and Evaluation Technical Assistance, 9363-9364 2022-03520 Coast Guard Coast Guard RULES Safety Zone: Coast Guard Island, Alameda, CA, 9244-9245 2022-03542 Commerce Commerce Department See Census Bureau See International Trade Administration See National Institute of Standards and Technology See National Oceanic and Atmospheric Administration See Patent and Trademark Office Committee for Purchase Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List;

Additions and Deletions, 9327-9328 2022-03604 2022-03606 Defense Department Defense Department See Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certain Federal Acquisition Regulation Part 9 Requirements, 9357-9359 2022-03567 Government Property, 9353-9354 2022-03562 Service Contracting, 9356 2022-03564 Subcontract Consent and Contractors' Purchasing System Review, 9354-9355 2022-03566 Travel Costs, 9356-9357 2022-03563 Value Engineering Requirements, 9359-9360 2022-03561 Defense Nuclear Defense Nuclear Facilities Safety Board NOTICES Performance Review Board Members, 9329-9330 2022-03509 Education Department Education Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Connecting Adults to Success: Career Navigator Training Study, 9337 2022-03501 Program for the International Assessment of Adult Competencies Cycle II 2022 Main Study, 9330-9331 2022-03543 Applications for New Awards: Indian Education Discretionary Grant Programs; Native Youth Community Program, 9331-9337 2022-03510 Energy Department Energy Department See Federal Energy Regulatory Commission NOTICES Meetings: Advanced Scientific Computing Advisory Committee, 9339-9340 2022-03489 Environmental Management Site-Specific Advisory Board, Nevada, 9338 2022-03599 Environmental Management Site-Specific Advisory Board, Northern New Mexico, 9338 2022-03598 Environmental Management Site-Specific Advisory Board, Paducah, 9340 2022-03597 Environmental Management Site-Specific Advisory Board, Savannah River Site, 9338-9339 2022-03601 Environmental Protection Environmental Protection Agency RULES Pesticide Tolerance;

Exemptions, Petitions, Revocations, etc.: Fluopyram, 9245-9250 2022-03385 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Hazardous Remediation Waste Management Requirements Contaminated Media, 9346-9347 2022-03512 New Source Performance Standards for Surface Coating of Large Appliances, 9346 2022-03511 Environmental Impact Statements; Availability, etc.: Weekly Receipt, 9345-9346 2022-03581 Farm Service Farm Service Agency NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Agricultural Foreign Investment Disclosure Act Report, 9310 2022-03487 Servicing Minor Program Loans, 9309-9310 2022-03547 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Airbus Helicopters, 9277-9280 2022-03515 Viking Air Limited (Type Certificate Previously Held by Bombardier Inc. and de Havilland, Inc.) Airplanes; Correction, 9274-9276 2022-03459 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Airspace Authorizations in Controlled Airspace, 9414-9415 2022-03506 Aviation Insurance, 9413-9414 2022-03486 Petition for Exemption; Summary: Columbia Helicopters, 9412 2022-03586 Longhorn Helicopters, Inc. dba, Helicopter Institute, 9414 2022-03544 Proposed Release of Airport Property for Non-Aeronautical Use: Pocahontas Municipal Airport, Pocahontas, AR, 9413 2022-03553 Federal Communications Federal Communications Commission RULES Auction of Construction Permits for Full Power Television Stations:

Filing Requirements, Minimum Opening Bids, Upfront Payments, and Other Procedures for Auction 112, 9250-9270 2022-03348 Federal Energy Federal Energy Regulatory Commission NOTICES Application: Southern California Edison Co., 9343-9344 2022-03573 Combined Filings, 9340-9342 2022-03574 2022-03575 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Powell River Energy, Inc., 9342-9343 2022-03582 Petition for Waiver: Black Hills Shoshone Pipeline, LLC, 9341-9342 2022-03585 Request under Blanket Authorization:

Northern Natural Gas Co., 9344-9345 2022-03583 Federal Highway Federal Highway Administration PROPOSED RULES Drug Offender's Driver's License Suspension, 9297-9303 2022-03172 NOTICES Environmental Impact Statements; Availability, etc.: Proposed Highway Project; Cities of Chesapeake and Suffolk, VA, 9415-9419 2022-03397 Federal Motor Federal Motor Carrier Safety Administration NOTICES Exemption Application: Parts and Accessories Necessary for Safe Operation; Pi Variables, Inc., 9419-9420 2022-03568 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9348-9349 2022-03485 Change in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 9347-9348 2022-03603 Federal Trade Federal Trade Commission NOTICES Horseracing Integrity and Safety Authority Assessment Methodology, 9349-9353 2022-03717 Fish Fish and Wildlife Service NOTICES Charter Renewal: Hunting and Wildlife Conservation Council; Request for Nominations, 9374-9375 2022-03498 Endangered and Threatened Species: Receipt of an Incidental Take Permit Application and Low-Effect Habitat Conservation Plan for the Big Tujunga Dam Project, Los Angeles County Department of Public Works, Los Angeles County, CA, 9373-9374 2022-03528 Food and Drug Food and Drug Administration RULES Medical Devices:

Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access, 9240-9242 2022-03496 Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System, 9237-9239 2022-03504 Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator, 9242-9244 2022-03540 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Center for Devices and Radiological Health Appeals Processes, 9365-9366 2022-03546 Guidance: Product-Specific Guidances, 9366-9368 2022-03248 Forest Forest Service NOTICES Meetings: Modoc County Resource Advisory Committee, 9310-9311 2022-03549 General Services General Services Administration PROPOSED RULES Federal Management Regulation: Replacement of Personal Property Pursuant to the Exchange/Sale Authority, 9303-9306 2022-03379 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Certain Federal Acquisition Regulation Part 9 Requirements, 9357-9359 2022-03567 Government Property, 9353-9354 2022-03562 Service Contracting, 9356 2022-03564 Subcontract Consent and Contractors' Purchasing System Review, 9354-9355 2022-03566 Travel Costs, 9356-9357 2022-03563 Value Engineering Requirements, 9359-9360 2022-03561 Health and Human Health and Human Services Department See Agency for Healthcare Research and Quality See Centers for Disease Control and Prevention See Children and Families Administration See Food and Drug Administration See Health Resources and Services Administration See National Institutes of Health Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Rural Communities Opioid Response Program Performance Measures, 9368-9369 2022-03499 Homeland Homeland Security Department See Coast Guard See U.S. Customs and Border Protection Interior Interior Department See Fish and Wildlife Service See Land Management Bureau International Trade Adm International Trade Administration NOTICES Amended Dates and Deadlines: Trade Mission to Central America in Conjunction with The Trade Americas and the US-UK Financial Innovation Partnership Trade Mission, 9317-9318 2022-03526 Amendment for Clean Air Trade Mission to India, 9316-9317 2022-03527 Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Circular Welded Carbon-Quality Steel Pipe from Oman, Pakistan, and the United Arab Emirates, 9315-9316 2022-03532 Scope Ruling Applications Filed, 9314-9315 2022-03531 Meetings: Environmental Technologies Trade Advisory Committee, 9319-9320 2022-03525 Recruitment for the Clean EDGE Asia Business Development Mission to Indonesia and Vietnam, 9320-9322 2022-03502 Request for Applications: United States-Brazil CEO Forum, 9313-9314 2022-03519 Requests for Nominations: U.S. Section to the United States-India CEO Forum, 9318-9319 2022-03514 International Trade Com International Trade Commission NOTICES Complaint:

Certain Power Semiconductors, and Mobile Devices and Computers Containing Same, 9382-9383 2022-03521 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Networking Devices, Computers, and Components Thereof and Systems Containing the Same, 9382 2022-03505 Certain Toner Supply Containers and Components Thereof, 9379-9380 2022-03557 Certain Vaporizer Cartridges and Components Thereof, 9380-9382 2022-03518 Lemon Juice from Brazil and South Africa, 9378 2022-03559 Steel Nails from India, Oman, Sri Lanka, Thailand, and Turkey, 9378-9379 2022-03558 Justice Department Justice Department NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9384-9386 2022-03577 2022-03578 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Leased/Charter/Contract Personnel Expedited Clearance Request, 9384 2022-03576 Proposed Consent Decree: Clean Water Act, Emergency Planning and Community Right-to-Know Act, and Comprehensive Environmental Response, Compensation and Liability Act, 9386 2022-03497 Labor Department Labor Department See Occupational Safety and Health Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Occupational Safety and Health Act Variance Regulations, 9386-9387 2022-03535 Standard on Blasting Operations and the Use of Explosives, 9387 2022-03534 Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Leasing of Solid Minerals Other than Coal and Oil Shale, 9375-9376 2022-03523 Intent to Amend the California Desert Conservation Area Plan for the Morongo Highway 62 Communication Site Project, San Bernardino County, CA, 9376-9377 2022-03475 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Certain Federal Acquisition Regulation Part 9 Requirements, 9357-9359 2022-03567 Government Property, 9353-9354 2022-03562 Service Contracting, 9356 2022-03564 Subcontract Consent and Contractors' Purchasing System Review, 9354-9355 2022-03566 Travel Costs, 9356-9357 2022-03563 Value Engineering Requirements, 9359-9360 2022-03561 National Institute National Institute of Standards and Technology NOTICES Meetings: National Construction Safety Team Advisory Committee, 9322-9323 2022-03560 National Institute National Institutes of Health NOTICES Meetings:

Center for Scientific Review, 9369-9371 2022-03541 2022-03595 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone off Alaska: Pacific Cod by Vessels Using Pot Gear in the Central Regulatory Area of the Gulf of Alaska, 9273 2022-03637 Pacific Island Fisheries: Rebuilding Plan for Guam Bottomfish, 9271-9273 2022-03517 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Licensing of Private Remote-Sensing Space Systems, 9323-9324 2022-03419 Meetings:

New England Fishery Management Council, 9324 2022-03491 Pacific Fishery Management Council, 9324-9326 2022-03492 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 9390-9391 2022-03639 2022-03731 2022-03737 Navy Navy Department NOTICES Environmental Impact Statements; Availability, etc.: Land Acquisition for the Washington Navy Yard, Washington, DC, 9328-9329 2022-03632 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals: Domestic Licensing of Source Material, 9392-9393 2022-03530 General Licensee Registration, 9396-9397 2022-03545 Environmental Impact Statements; Availability, etc.: Kairos Energy, LLC; Kairos Test Reactor, 9394-9396 2022-03537 Exemption: Multiple; in Response to COVID-19 Public Health Emergency, 9391-9392 2022-03589 NextEra Energy Duane Arnold, LLC; Duane Arnold Energy Center Independent Spent Fuel Storage Installation, 9393-9394 2022-03590 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Nationally Recognized Testing Laboratories:

TUV SUD America, Inc.; Expansion of Recognition and Proposed Modification to the NRTL Program's List of Appropriate Test Standards, 9387-9389 2022-03536 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Patents for Humanity Program, 9326-9327 2022-03513 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Death Benefits under the Federal Employees' Retirement System, etc., 9397-9398 2022-03580 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 9398 2022-03571 Securities Securities and Exchange Commission PROPOSED RULES Whistleblower Program Rules, 9280-9297 2022-03223 NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9403 2022-03493 Order Granting Petition for Review: New York Stock Exchange, LLC, NYSE American LLC, NYSE Arca, Inc., NYSE Chicago, Inc., and NYSE National, Inc., 9404 2022-03524 Self-Regulatory Organizations; Proposed Rule Changes: Cboe BZX Exchange, Inc., 9399 2022-03494 Cboe EDGX Exchange, Inc., 9399-9403 2022-03495 New York Stock Exchange, LLC, 9398 2022-03552 Small Business Small Business Administration NOTICES Agency Information Collection Activities;

Proposals, Submissions, and Approvals, 9404-9405 2022-03508 Disaster Declaration: Kentucky; Amendment No. 5, 9405 2022-03550 Meetings: Advisory Committee on Veterans Business Affairs, 9405 2022-03529 State Department State Department NOTICES Culturally Significant Object Being Imported for Exhibition: Igshaan Adams: Desire Lines, 9405-9406 2022-03507 Winslow Homer: Crosscurrents, 9406 2022-03490 Surface Transportation Surface Transportation Board NOTICES Control: Canadian Pacific Railway Ltd., Canadian Pacific Railway Co., Soo Line Railroad Co., et al.;

Kansas City Southern, The Kansas City Southern Railway Co., Gateway Eastern Railway Co. et al., 9406-9412 2022-03579 Codex The U.S. Codex Office NOTICES Meetings: Codex Alimentarius Commission, Committee on Fresh Fruits and Vegetables, 9308-9309 2022-03592 Transportation Department Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Motor Carrier Safety Administration Treasury Treasury Department See Alcohol and Tobacco Tax and Trade Bureau Customs U.S.

Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Customs-Trade Partnership against Terrorism Program and Customs-Trade Partnership against Terrorism Trade Compliance Program, 9371-9373 2022-03503 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws. To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. 87 34 Friday, February 18, 2022 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No.

FDA-2021-N-1343] Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the integrated continuous glucose monitoring system's classification.

We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices. DATES: This order is effective February 18, 2022. The classification was applicable on March 27, 2018. FOR FURTHER INFORMATION CONTACT: Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357, *Ryan.Lubert@fda.hhs.gov.* SUPPLEMENTARY INFORMATION:

I. Background Upon request, FDA has classified the integrated continuous glucose monitoring system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment. The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device.

Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act).

As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device. II. De Novo Classification On December 8, 2017, FDA received Dexcom, Inc.'s request for De Novo classification of the Dexcom G6 Continuous Glucose Monitoring System.

FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify 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 that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)).

After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device. Therefore, on March 27, 2018, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 862.1355. 1 We have named the generic type of device “integrated continuous glucose monitoring system (iCGM),” and it is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control. 1 FDA notes that the ACTION caption for this final order is styled as “Final amendment; final order,” rather than “Final order.

” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's

(OFR)interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. 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—Integrated Continuous Glucose Monitoring System Risks and Mitigation Measures Identified risks Mitigation measures Clinical action based on falsely high or falsely low inaccurate glucose values or inaccurate alerts may lead to inappropriate treatment decisions General Controls and special controls

(1)(21 CFR 862.1355(b)(1)),

(2)(21 CFR 862.1355(b)(2)),

(3)(21 CFR 862.1355(b)(3)),

(4)(21 CFR 862.1355(b)(4)),

(5)(21 CFR 862.1355(b)(5)),

(6)(21 CFR 862.1355(b)(6)), and

(7)(21 CFR 862.1355(b)(7)). Clinical action in pediatric patients based on falsely high or falsely low inaccurate values or inaccurate alerts due to poorer or different performance in pediatric populations General Controls and special controls

(1)(21 CFR 862.1355(b)(1)),

(2)(21 CFR 862.1355(b)(2)),

(3)(21 CFR 862.1355(b)(3)),

(4)(21 CFR 862.1355(b)(4)),

(5)(21 CFR 862.1355(b)(5)),

(6)(21 CFR 862.1355(b)(6)), and

(7)(21 CFR 862.1355(b)(7)). The inability to make appropriate treatment decisions when glucose values are unavailable due to sensor signal dropout or loss of communication with digitally connected devices General Controls and special controls (1)(vii) (21 CFR 862.1355(b)(1)(vii)),

(2)(21 CFR 862.1355(b)(2)),

(3)(21 CFR 862.1355(b)(3)),

(6)(21 CFR 862.1355(b)(6)), and

(7)(21 CFR 862.1355(b)(7)). Patient harm due to insecure transmission of data General Controls and special control

(2)(21 CFR 862.1355(b)(2)). Use of an iCGM as part of another digitally connected medical device system, such as an automated insulin dosing

(AID)system, when the iCGM has inadequate analytical or clinical performance to support the intended use of the digitally connected device General Controls and special controls

(2)(21 CFR 862.1355(b)(2)),

(6)(21 CFR 862.1355(b)(6)), and

(7)(21 CFR 862.1355(b)(7)). FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. III. Analysis of Environmental Impact The Agency has 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. IV. Paperwork Reduction Act of 1995 This final order establishes special controls that refer 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. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality systems regulations, have been approved under OMB control number 0910-0073; 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 862 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 862 is amended as follows: PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 1. The authority citation for part 862 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. 2. Add § 862.1355 to subpart B to read as follows: § 862.1355 Integrated continuous glucose monitoring system.

(a)*Identification.* An integrated continuous glucose monitoring system

(iCGM)is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

(b)*Classification.* Class II (special controls). The special controls for this device are:

(1)Design verification and validation must include the following:

(i)Robust clinical data demonstrating the accuracy of the device in the intended use population.

(ii)The clinical data must include a comparison between iCGM values and blood glucose values in specimens collected in parallel that are measured on an FDA-accepted laboratory-based glucose measurement method that is precise and accurate, and that is traceable to a higher order ( *e.g.,* an internationally recognized reference material and/or method).

(iii)The clinical data must be obtained from a clinical study designed to fully represent the performance of the device throughout the intended use population and throughout the measuring range of the device.

(iv)Clinical study results must demonstrate consistent analytical and clinical performance throughout the sensor wear period.

(v)Clinical study results in the adult population must meet the following performance requirements:

(A)For all iCGM measurements less than 70 milligrams/deciliter (mg/dL), the percentage of iCGM measurements within ±15 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 85 percent.

(B)For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 70 percent.

(C)For all iCGM measurements greater than 180 mg/dL, the percentage of iCGM measurements within ±15 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 80 percent.

(D)For all iCGM measurements less than 70 mg/dL, the percentage of iCGM measurements within ±40 mg/dL of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 98 percent.

(E)For all iCGM measurements from 70 mg/dL to 180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.

(F)For all iCGM measurements greater than180 mg/dL, the percentage of iCGM measurements within ±40 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 99 percent.

(G)Throughout the device measuring range, the percentage of iCGM measurements within ±20 percent of the corresponding blood glucose value must be calculated, and the lower one-sided 95 percent confidence bound must exceed 87 percent.

(H)When iCGM values are less than 70 mg/dL, no corresponding blood glucose value shall read above 180 mg/dL.

(I)When iCGM values are greater than 180 mg/dL, no corresponding blood glucose value shall read less than 70 mg/dL.

(J)There shall be no more than 1 percent of iCGM measurements that indicate a positive glucose rate of change greater than 1 mg/dL per minute (/min) when the corresponding true negative glucose rate of change is less than −2 mg/dL/min as determined by the corresponding blood glucose measurements.

(K)There shall be no more than 1 percent of iCGM measurements that indicate a negative glucose rate of change less than −1 mg/dL/min when the corresponding true positive glucose rate of change is greater than 2 mg/dL/min as determined by the corresponding blood glucose measurements.

(vi)Data demonstrating similar accuracy and rate of change performance of the iCGM in the pediatric population as compared to that in the adult population, or alternatively a clinical and/or technical justification for why pediatric data are not needed, must be provided and determined by FDA to be acceptable and appropriate.

(vii)Data must demonstrate that throughout the claimed sensor life, the device does not allow clinically significant gaps in sensor data availability that would prevent any digitally connected devices from achieving their intended use.

(2)Design verification and validation must include a detailed strategy to ensure secure and reliable means of iCGM data transmission to provide real-time glucose readings at clinically meaningful time intervals to devices intended to receive the iCGM glucose data.

(3)Design verification and validation must include adequate controls established during manufacturing and at product release to ensure the released product meets the performance specifications as defined in paragraphs (b)(1) and (b)(2) of this section.

(4)The device must demonstrate clinically acceptable performance in the presence of clinically relevant levels of potential interfering substances that are reasonably present in the intended use population, including but not limited to endogenous substances and metabolites, foods, dietary supplements, and medications.

(5)The device must include appropriate measures to ensure that disposable sensors cannot be used beyond its claimed sensor wear period.

(6)Design verification and validation must include results obtained through a usability study that demonstrates that the intended user can use the device safely and obtain the expected glucose measurement accuracy.

(7)The labeling required under § 809.10(b) of this chapter must include a separate description of the following sensor performance data observed in the clinical study performed in conformance with paragraph (b)(1) of this section for each intended use population, in addition to separate sensor performance data for each different iCGM insertion or use sites ( *e.g.,* abdomen, arm, buttock):

(i)A description of the accuracy in the following blood glucose concentration ranges: less than 54 mg/dL, 54 mg/dL to less than 70 mg/dL, 70 to 180 mg/dL, greater than 180 to 250 mg/dL, and greater than 250 mg/dL.

(ii)A description of the accuracy of positive and negative rate of change data.

(iii)A description of the frequency and duration of gaps in sensor data.

(iv)A description of the true, false, missed, and correct alert rates and a description of the available glucose concentration alert settings, if applicable.

(v)A description of the observed duration of iCGM life for the device. Dated: February 11, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022-03504 Filed 2-17-22; 8:45 am]

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