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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
documents/acceptance-review-de-novoclassification-requests.
17. FDAs guidance Guidance for Industry and Food and Drug Administration StaffUser Fees for 513g Requests for Information, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/userfees-513g-requests-information.
18. FDAs guidance FDA and Industry Procedures for Section 513g Requests for Information under the Federal Food, Drug, and Cosmetic Act, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/fda-and-industry-proceduressection-513g-requests-informationunder-federal-food-drug-and-cosmetic.
19. Emergency Use Authorization of Medical Products and Related Authorities, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
emergency-use-authorization-medicalproducts-and-related-authorities.
20. FDAs full analysis of economic impacts is available in the Docket No. FDA
2018N0236 for this rule and at https
www.fda.gov/AboutFDA/Reports ManualsForms/Reports/Economic Analyses/default.htm.

List of Subjects in 21 CFR Part 860
Administrative practice and procedure, 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 860 is amended as follows:
PART 860MEDICAL DEVICE
CLASSIFICATION PROCEDURES
1. The authority citation for part 860
is revised to read as follows:

Authority: 21 U.S.C. 321h, 353g, 360c, 360d, 360e, 360i, 360j, 371, 374.

2. In part 860, remove all references to the act and add in their place the Federal Food, Drug, and Cosmetic Act.
3. Amend 860.1 by revising paragraph b to read as follows:

860.1

Scope.

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b This part prescribes the criteria and procedures to be used by advisory committees, including classification panels, where applicable, in making their recommendations, and by the Commissioner in making the Commissioners determinations regarding the class of regulatory control class I, class II, or class III appropriate for particular devices. Supplementing the general Food and Drug Administration procedures governing advisory committees part 14 of this chapter, this part also provides procedures for manufacturers,
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importers, and other interested persons to participate in proceedings to classify and reclassify devices. This part also describes the type of data required for determination of the safety and effectiveness of a device, and the circumstances under which information submitted to advisory committees, including classification panels, or to the Commissioner in connection with classification and reclassification proceedings, will be available to the public.
4. Revise 860.3 to read as follows:
860.3

Definitions.

For the purposes of this part:
Class means one of the three categories of regulatory control for medical devices, defined as follows:
Class I means the class of devices that are subject only to the general controls authorized by or under sections 501
adulteration, 502 misbranding, 510
registration, 516 banned devices, 518
notification and other remedies, 519
records and reports, and 520 general provisions of the Federal Food, Drug, and Cosmetic Act. A device is in class I if:
1 General controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or 2 There is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness or injury.
Class II means the class of devices that is or eventually will be subject to special controls. A device is in class II
if general controls alone are insufficient to provide reasonable assurance of its safety and effectiveness and there is sufficient information to establish special controls, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510k of the Federal Food, Drug, and Cosmetic Act, recommendations, and other appropriate actions as the Commissioner deems necessary to provide such assurance. For a device that is purported or represented to be for use in supporting or sustaining human life, the Commissioner shall examine
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and identify the special controls, if any, which are necessary to provide adequate assurance of safety and effectiveness, and describe how such controls provide such assurance.
Class III means the class of devices for which premarket approval is or will be required in accordance with section 515
of the Federal Food, Drug, and Cosmetic Act. A device is in class III if insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness, or that application of special controls described in the definition of Class II
in this section in addition to general controls, would provide such assurance, and if, in addition, the device is lifesupporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
Classification panel means one of the several advisory committees established by the Commissioner under section 513
of the Federal Food, Drug, and Cosmetic Act and part 14 of this chapter for the purpose of making recommendations to the Commissioner on the classification and reclassification of devices and for other purposes prescribed by the Federal Food, Drug, and Cosmetic Act or by the Commissioner.
Classification regulation means a section under parts 862 through 892 of this chapter that contains the identification general description and intended use and classification class I, II or III of a single device type or more than one related device types.
Commissioner means the Commissioner of Food and Drugs, Food and Drug Administration, United States Department of Health and Human Services, or the Commissioners designee.
De Novo request means any submission under section 513f2 of the Federal Food, Drug, and Cosmetic Act for a medical device, requesting classification into class I or class II, including all information submitted with or incorporated by reference therein.
FDA means the Food and Drug Administration.
General controls mean the controls authorized by or under sections 501
adulteration, 502 misbranding, 510
registration, listing, and premarket notification, 516 banned devices, 518
notification and other remedies, 519
records, reports, and unique device identification, and 520 general provisions of the Federal Food, Drug, and Cosmetic Act.

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