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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations
the FD&C Act, this document will refer only to the requirement for the filing and obtaining approval of a PMA.
On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act FDASIA Pub. L.
112144. Section 608b of FDASIA
amended section 515b of the FD&C
Act, changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.
Section 515b1 of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III
device, the following must occur: 1
Publication of a proposed order in the Federal Register; 2 a meeting of a device classification panel described in section 513b of the FD&C Act; and 3
consideration of comments to a public docket.
In June 2013, FDA held a meeting of a device classification panel described in section 513b of the FD&C Act to discuss the classification of multiple use blood lancets for multiple patient use Ref. 1. Although, to FDAs knowledge, no device is currently being marketed for this use, one device has been cleared for this use. This device classification panel meeting discussed whether multiple use blood lancets for multiple patient use should be reclassified into class III or remain in class I, and the discussion included whether PMAs should be required for these devices.
The panel recommended that, 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, the device should be reclassified into class III. FDA is not aware of new information that would provide a basis for a different recommendation or findings.
On March 3, 2016, FDA published a proposed order 81 FR 11140 to reclassify multiple use blood lancets for multiple patient use from class I
general controls, exempt from premarket notification, into class III
premarket approval. On March 3, 2016, FDA published a second proposed order 81 FR 11151 to require the filing of a PMA following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
Section 515b3 of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device
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classification panel described in section 513b of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513e of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act 21 U.S.C. 360f.
A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA
issues a final order requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act becomes effective, whichever is later section 501f2B of the FD&C Act 21
U.S.C. 351f2B. Elsewhere in this issue of the Federal Register, FDA is issuing a final order to reclassify multiple use blood lancets for multiple patient use from class I to class III.
Therefore, the date by which a PMA for multiple use blood lancets for multiple patient use must be filed is May 22, 2024. If a PMA is not filed for such device by May 22, 2024, as specified in section 501f2B of the FD&C Act, then the device would be deemed adulterated under section 501f of the FD&C Act unless the device is distributed for investigational use under an approved application for an investigational device exemption IDE.
II. Public Comments on Proposed Order and FDA Response In response to the proposed order to require the filing of a PMA for multiple use blood lancets for multiple patient use, FDA received two comments. The comments and FDA responses to the comments are summarized in this section. The number assigned to each comment is purely for organizational purposes and does not signify the comments value or importance or the order in which it was submitted.
Comment 1 Comment supports regulation of blood lancets to lower the risk of injury associated with such devices during home use, including use by patients who may have shaking hands due to low blood sugar.
Response 1 FDA agrees that blood lancets, including multiple use blood lancets for multiple patient use, should be regulated to provide a reasonable assurance of the safety and effectiveness for these devices.
Comment 2 Comment recommends banning multiple use blood lancets for multiple patient use because the devices present a potential unreasonable risk of illness that cannot be adequately
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addressed through the PMA process and single patient lancets are available.
Response 2 Section 516 of the FD&C
Act gives FDA the authority to ban a device. Section 516 authorizes FDA to ban a device when, on the basis of all available data and information, FDA
finds that the device presents substantial deception or an unreasonable and substantial risk of illness or injury and, where such deception or risk could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary of the Department of Health and Human Services Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period.
As stated earlier in this document, FDA issued a proposed order 81 FR
11151 under section 515b of the FD&C
Act to require the filing of PMAs for multiple use blood lancets for multiple patient use following reclassification, which would require an individual demonstration of a reasonable assurance of safety and effectiveness for such a device before it may be marketed. In the proposed order, FDA recognized and agreed with the recommendations from the Panel 1 that based on the available scientific evidence, multiple use blood lancets for multiple patient use should be reclassified to class III because these devices present a potential unreasonable risk of illness or injury and insufficient information exists to establish special controls for these devices because there is no evidence that they can be adequately cleaned and disinfected and there is no proven method of doing so.
To FDAs knowledge, although one device has been cleared for this use, no device is currently being marketed for this use. FDA believes that evidence may be provided through a PMA to demonstrate a reasonable assurance of safety and effectiveness of the device.
Additionally, such evidence may provide additional information to allow FDA to impose controls to mitigate the risk and more clearly characterize the benefits of these devices. At this time and on the basis of all available data and information, FDA does not believe that this device presents substantial deception or an unreasonable and 1 See FDAs General and Plastic Surgery Devices Panel meeting transcript for the June 26, 2013, meeting Ref. 1 discussion at page 104.

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