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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1

substantial risk of illness or injury to support a ban.
III. The Final Order Under section 515b3 of the FD&C
Act, FDA is adopting its findings as published in the proposed order 81 FR
11151 and is issuing this final order to require the filing of a PMA for multiple use blood lancets for multiple patient use. This final order will revise 21 CFR
part 878. Elsewhere in this issue of the Federal Register, FDA is reclassifying multiple use blood lancets for multiple patient use into class III under section 513e of the FD&C Act.
Under the final order, a PMA is required to be filed on or before May 22, 2024, for any of these preamendments class III devices that were in commercial distribution before May 28, 1976, or that have been found by FDA to be substantially equivalent to such a device on or before May 22, 2024. An applicant of a device subject to this order that was legally in commercial distribution before May 28, 1976, or that has been found to be substantially equivalent to a device that was legally in commercial distribution before May 28, 1976, may continue marketing such class III device during FDAs review of the PMA
provided that the PMA is filed on or May 22, 2024. However, if FDA denies approval of the PMA, then the device will be deemed adulterated under section 501f1A of the FD&C Act, and commercial distribution of the device must cease immediately. Any other device subject to this order is required to have an approved PMA in effect before it may be marketed. FDA
intends to review any PMA for the device within 180 days of the date of filing. FDA cautions that under section 515d1Bi of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA
beyond 180 days unless the Agency finds that the continued availability of the device is necessary for the public health.
If a PMA for any of the preamendments class III devices subject to this order is not filed on or before May 22, 2024, that device will be deemed adulterated under section 501f1A of the FD&C Act, and commercial distribution of the device must cease immediately. FDA requests that manufacturers take action to prevent the further use of multiple use blood lancets for multiple patient use for which no PMA has been filed.
The device may, however, be distributed for investigational use, if the applicable requirements of the IDE
regulations part 812 21 CFR part 812, including obtaining IDE approval, are
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met on or before May 22, 2024. There will be no extended period for filing an IDE or exemption from the IDE
requirements see 812.2d, and clinical studies may not be initiated without appropriate IDE approvals, as required.
Until the date when a PMA must be filed, any multiple use blood lancet for multiple patient use not in commercial distribution as of the effective date of this order is subject to premarket notification under section 510k of the FD&C Act 21 U.S.C. 360k and 21 CFR
part 807, subpart E, unless the device is exempt from 510k because the applicable requirements of part 812, including obtaining IDE approval, are met.
IV. Codification of Orders Prior to the amendments by FDASIA, section 515b of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found substantially equivalent to preamendments devices. Section 515b of the FD&C Act, as amended by FDASIA, provides for FDA to require approval of an application for premarket approval for such devices by issuing a final order following the issuance of a proposed order in the Federal Register.
FDA will continue to codify the requirement for an application for premarket approval in the Code of Federal Regulations CFR. Therefore, under section 515b1 of the FD&C Act, as amended by FDASIA, in this final order, FDA is requiring approval of an application for premarket approval for multiple use blood lancets for multiple patient use and the Agency is making the language in 21 CFR 878.4850
consistent with this final order.
V. Analysis of Environmental Impact We have determined under 21 CFR
25.34b 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.
VI. Paperwork Reduction Act of 1995
FDA concludes that this final order contains no new collection of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required. This final order refers to previously approved FDA
collections of information. These collections of information are subject to review by OMB under the PRA. The
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collections of information in 21 CFR
part 814, subparts A through E, have been approved under OMB control number 09100231. The collections of information in part 807, subpart E, have been approved under OMB control number 09100120. The collections of information in 21 CFR part 801 have been approved under OMB control number 09100485. The collections of information in part 812 have been approved under OMB control number 09100078.
VII. Reference The following reference is on display at the Dockets Management Staff HFA
305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it is also available electronically at https
www.regulations.gov. FDA has verified the website address, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. FDAs General and Plastic Surgery Devices Panel meeting transcript and other meeting materials for the June 26, 2013, meeting, available at: https
wayback.archive-it.org/7993/
20170113134353/https www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/
MedicalDevices/MedicalDevices AdvisoryCommittee/GeneralandPlastic SurgeryDevicesPanel/UCM362831.pdf;
and https wayback.archive-it.org/7993/
20170405193132/https:/www.fda.gov/
AdvisoryCommittees/CommitteesMeeting Materials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/
GeneralandPlasticSurgeryDevicesPanel/
ucm349426.htm.

List of Subjects in 21 CFR Part 878
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 878, as amended elsewhere in this issue of the Federal Register, is further amended as follows:
PART 878GENERAL AND PLASTIC
SURGERY DEVICES
1. The authority citation for part 878
continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

2. In 878.4850, add paragraph d3
to read as follows:

878.4850

Blood lancets.

d

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