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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
devices that are of differing generic types. Under the current review process for the Center for Devices and Radiological Health CDRH, bundling of multiple devices or indications for use are acceptable for 510k submission when the devices present scientific and regulatory issues that can most efficiently be addressed during the course of one premarket review Ref.
10. CDRH will make a determination of acceptable bundling of devices on a case-by-case basis.
Comment 13 Some comments stated that all multiple use lancets should be class III.
Response 13 FDA disagrees with this comment. FDA believes the regulatory requirements for blood lancets should be based upon the indications for use of the device and the risk of the device when used as intended. After reviewing the new scientific data supporting the identified risks to health, the Panel recommended that reclassifying subset 3, multiple use for single patient use blood lancets from class I general controls to class II special controls because multiple use blood lancet devices for single use patients do not present a potential unreasonable risk of illness or injury due to the inherent and significantly increased risk of bloodborne pathogen transmission as compared to multiple patient blood lancets Ref. 2. As stated above in response to Comment 2 in this section and in the 513e Proposed Order 81 FR
11140 at 11148, FDA believes sufficient information exists to establish special controls for mitigating the risks to health for subset 3 multiple use for single patient use only blood lancets to provide a reasonable assurance of safety and effectiveness of the device. Because multiple use blood lancets for multiple patient use present a potential unreasonable risk of illness or injury and insufficient information exists to establish special controls for multiple use blood lancets for multiple patient use, FDA reclassified the device into class III.
Comment 14 Some comments stated that the wording of the subtypes in the 513e Proposed Order were unclear and should be revised to distinguish between lancets and lancing medical devices.
Response 14 FDA understands the concerns of the commenter and is providing in this final order language to explain whether blades are attached to the base in each of the four subsets of blood lancets. The base and blade combine to create the complete lancet.
For subset 1 and 2 lancets, the blade is attached to the base with the entire unit being single use. In subset 3 and 4

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lancets, single use blades are attached to a multiuse base where the blade is discarded after each use, but each subset has a different labeling requirement. By definition, subsets 1 and 2 blood lancets do not have a blade that can be used independently of the base. Furthermore, FDA provides clear descriptions of special controls that apply to each component for subsets 1, 2, and 3. As discussed at the Panel, multiple use lancets for multiple patients present an unreasonable risk of illness or injury due to the inherent and significantly increased risk of bloodborne pathogen transmission and are therefore reclassified into class III. Therefore, FDA believes that the blood lancet definitions presented during the Panel meeting and provided in the 513e Proposed Order are complete and adequate.
Comment 15 Comment stated that FDAs increase of postmarket surveillance of blood glucose meter accuracy would provide greater impact on mitigating cross-contamination opportunities than reclassification of blood lancets.
Response 15 Postmarket surveillance of blood glucose meter accuracy is outside the scope of this regulatory action.
IV. The Final Order Under section 513e of the FD&C Act, FDA is adopting its findings as published in the preamble to the 513e Proposed Order for these devices 81 FR
11140. FDA is issuing this final order to reclassify single patient use only blood lancets devices from class I
general controls exempt from premarket notification into class II
special controls and subject to premarket review.4 FDA is reclassifying these devices based on the determination that general controls are insufficient to provide a reasonable assurance of safety and effectiveness for blood lancets and there is sufficient information to establish special controls to provide such assurance for single patient use only blood lancets subsets 1 to 3. FDA is also establishing special controls for each type of single patient use only blood lancet, which are set forth in 878.4850a2i through vi for single use only blood lancet with an 4 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 Registers 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.

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integral sharps injury prevention feature, 878.4850b2i through vi for single use only blood lancet without an integral sharps injury prevention feature, and 878.4850c2i through vii for multiple use blood lancet for single patient use only. FDA also intends not to enforce compliance with this final order until 1 year after its effective date for manufacturers of blood lancets for single patient use only that are currently marketed for sale prior to the publication of this final order, but do not already have a 510k clearance.
FDA is also issuing this final order to reclassify multiple use blood lancets for multiple patient use from class I
general controls exempt from premarket notification into class III
premarket approval. FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device. In addition, in the absence of an established positive benefit-risk profile, FDA has determined that the risks to health associated with the use of multiple patient use blood lancets identified previously present a potential unreasonable risk of illness or injury.
Elsewhere in this issue of the Federal Register, FDA has published a final order requiring the filing of a PMA or notice of completion of a PDP for multiple patient use blood lancets.
FDA has also modified the identification in 878.4800a for manual surgical instruments for general use to remove the blood lancet devices from this classification regulation and include them under a separate classification regulation 878.4850.
V. Premarket Notification Requirement for Single Patient Use Only Blood Lancets FDA is reclassifying single patient use only blood lancets from class I general controls exempt from premarket notification into class II special controls and subject to premarket review. Section 510m of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510k of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device.
FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness for the intended uses of all three types of single patient use only blood lancets. Therefore, these three device types are not exempt from premarket notification requirements.

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