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

FDA cleared several 510ks for blood lancets prior to exempting the device types from submission of a premarket notification. These cleared blood lancets, as well as any 510k-exempt blood lancets legally offered for sale on or before November 22, 2021, can serve as predicates for substantial equivalence purposes. In order for a single patient use only blood lancet to fall within this classification, 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.
VI. Implementation Strategy For the three types of blood lancets being reclassified from class I general controls to class II special controls, the special controls identified in this order are effective November 22, 2021.
For the fourth type of blood lancet being reclassified from class I to class III, FDA
is publishing a final order to require the filing of a PMA or notice of completion of a PDP elsewhere in this issue of the Federal Register.
Blood lancets for single patient use only that have not been offered for sale prior to November 22, 2021, or have been offered for sale but are required to submit a new 510k under 807.81a3: Manufacturers are required to obtain 510k clearance before marketing their devices after November 22, 2021. If a manufacturer markets such a device without receiving 510k clearance, then FDA would consider taking action against such a manufacturer, under its usual enforcement policies.
Blood lancets for single patient use only that have been offered for sale prior to November 22, 2021, and do not already have 510k clearance: FDA does not intend to enforce compliance with the 510k requirement or special controls until November 22, 2022. After that date, if a manufacturer continues to market such a device but does not have a 510k clearance or FDA determines that the device is not substantially equivalent or not compliant with the special controls, then FDA would consider taking action against such manufacturer under its usual enforcement policies.
For blood lancets for single patient use that have prior 510k clearance, FDA would accept a new 510k and would issue a new clearance letter, as appropriate, indicating substantial equivalence and compliance with the special controls. These devices could serve as predicates for new devices.
These clearance letters would be made publicly available in FDAs 510k database, and compliance with special
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controls at the time of clearance would be stated in the publicly available 510k Summary posted in this database.
Because many blood lancets for single patient use are non-prescription overthe-counter devices, FDA believes that our public database is a transparent tool allowing consumers to confirm that their devices have been submitted under a new 510k and demonstrated conformance to the applicable special controls.
The timeframes set forth in this section also apply to compliance with requirements for device labeling part 801 21 CFR part 801, including the UDI labeling requirements part 801, subpart B, as well as device tracking requirements 21 CFR part 821, device reporting requirements 21 CFR part 803, and GUDID data submission requirements 21 CFR part 830.
VII. Codification of Orders Prior to the amendments by the Food and Drug Administration Safety and Innovation Act FDASIA, section 513e of the FD&C Act provided for FDA to issue regulations to reclassify devices.
Although section 513e as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations CFR. Changes resulting from final orders will appear in the CFR
as changes to codified classification determinations or as newly codified orders. Therefore, under section 513e1Ai of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in 21
CFR 878.4800 related to the classification of blood lancets as class I
devices and codifying the reclassification of four types of blood lancets in 21 CFR 878.4850: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only into class II, and multiple use blood lancet for multiple patient use into class III.
VIII. Analysis of Environmental Impact The Agency has 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.

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IX. Paperwork Reduction Act of 1995
While this final order contains no collection of information, it does refer to previously approved FDA collections 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 for this final order.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 807, subpart E, have been approved under OMB
control number 09100120; the 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 21 CFR part 820 have been approved under OMB control number 09100073; the collections of information in 21 CFR part 830 have been approved under OMB control number 09100720; and the collections of information in 21 CFR parts 800, 801
and 809 have been approved under OMB control number 09100485.
The labeling provisions in proposed 878.4850a2vi, b2vi, and c2vii are not subject to review by OMB because they do not constitute a collection of information under the PRA. Rather, the following labeling: 1
For use only on a single patient.
Discard the entire device after use.; 2
For use only on a single patient.
Disinfect reusable components according to manufacturers instructions between each use.; 3 Used lancet blades must be safely discarded after a single use.; 4 Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.;
and 5 Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.
are a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public 5
CFR 1320.3c2.
X. References The following references marked with an asterisk are on display at the
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