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Federal Register / Vol. 86, No. 222 / Monday, November 22, 2021 / Rules and Regulations II. Background A. Classification The Federal Food, Drug, and Cosmetic Act FD&C Act 21 U.S.C. 301 et seq., as amended, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act 21
U.S.C. 360c established three categories classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I general controls, class II special controls, and class III
premarket approval.
Under section 513d of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments on May 28, 1976
generally referred to as preamendments devices are classified after FDA has: 1 Received a recommendation from a device classification panel an FDA advisory committee; 2 published the panels recommendation for comment, along with a proposed regulation classifying the device; and 3 published a final regulation classifying the device. FDA
has classified most preamendments devices under these procedures.

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B. Reclassification Section 513e1 of the FD&C Act sets forth the process for issuing a final order for reclassifying a device. Specifically, prior to the issuance of a final order reclassifying a 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.
FDA published a proposed order in the Federal Register of March 3, 2016
81 FR 11140, held a device classification panel meeting of the General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee, on June 26, 2013 the Panel, as described in section 513b of the FD&C Act with respect to the four different types of blood lancet devices, and considered comments from public dockets. Therefore, FDA has met the requirements under section 513e1 of the FD&C Act.
C. Requirement for Premarket Approval Elsewhere in this issue of the Federal Register, FDA has published a final order requiring the filing of a premarket approval application PMA or notice of completion of a product development protocol PDP for multiple patient blood lancets class III. In practice, the
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option of filing a notice of completion of a PDP has rarely been used by manufacturers. For simplicity, while corresponding requirements for PDPs remain available to manufacturers in response to a final order under section 515b of the FD&C Act 21 U.S.C.
360eb, this document will refer only to the requirement for the filing and obtaining approval of a PMA.
III. Public Comments in Response to the Proposed Order In the Federal Register of March 3, 2016, FDA published a proposed order to reclassify single patient use blood lancets from class I general controls exempt from premarket notification to class II special controls and to reclassify multiple patient blood lancets from class I general controls exempt from premarket notification to class III
premarket approval 513e Proposed Order, 81 FR 11140. On that same date, FDA also published a proposed order to require the filing of a PMA for multiple patient blood lancets 515b Proposed Order 81 FR 11151. The proposed orders also stated that FDA
proposed to amend 21 CFR part 878 to create a separate regulation under 878.4850 21 CFR 878.4850 for all blood lancet types previously identified with product codes FMK or JCA. The comment periods for both proposed orders closed on June 1, 2016.
The March 3, 2016, 513e Proposed Order received approximately 150
comments from industry, professional societies, trade organizations, and individual consumers by the close of the comment period. Certain comments have been grouped together under a single comment since the theme of the comments are similar in nature. The grouped comments and FDAs response to each grouping are summarized in this section. The number assigned to each comment is purely for organizational purposes and does not signify the comments value, importance, or the order in which it was received.
As previously set forth in the 513e Proposed Order, FDA identified the following four subsets of blood lancet devices:
1. A single use only blood lancet with an integral sharps injury prevention feature is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base including an integral sharps injury prevention feature that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it
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inoperable and incapable of further use subset 1;
2. A single use only blood lancet without an integral sharps injury prevention feature is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes subset 2;
3. A multiple use blood lancet for single patient use only is a multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes subset 3; and 4. A multiple use blood lancet for multiple patient use is a multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes subset 4.
Comment 1 Several comments generally agreed with the proposed reclassification of all four types of blood lancet devices. Some comments supported the proposed precautions and labeling special controls as necessary for healthcare providers and users of single patient use blood lancets. Other comments agreed that the risks to public health associated with use of multiple use blood lancets for multiple patients are sufficiently significant for FDA to reclassify this device type into class III
premarket approval.
Response 1 After considering the Panels recommendations and examination of scientific information Ref. 1, and previously described in the 513e Proposed Order 81 FR 11140 at 11142, FDA continues to believe that there is sufficient evidence to establish special controls that, together with general controls, provide a reasonable assurance of safety and effectiveness to reclassify single patient use only blood lancets to class II, as initially specified in the 513e Proposed Order. Further, FDA continues to believe that blood lancets for multiple patient use present a potential for unreasonable risk of illness or injury, that insufficient information exists for FDA to determine that special controls would provide a reasonable assurance of safety and effectiveness of the device, and that blood lancets for multiple patient use should be reclassified into class III.
Comment 2 Several comments stated that the evidence for a risk of infection was associated with the use of blood lancets in a professional care setting and therefore there was no evidence to
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