[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66177-66180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25381]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2016-M-0035]


Effective Date of Requirement for Premarket Approval for Blood 
Lancets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a final order to require the filing of a premarket approval 
application (PMA) or notice of completion of a product development 
protocol (PDP) following the reclassification of multiple use blood 
lancets for multiple patient use from class I to class III.

DATES: This order is effective on November 22, 2021.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, 
establishes 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 513(d)(1) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the Medical Device 
Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), May 28, 1976 
(generally referred to as ``preamendments devices''), are classified 
after FDA: (1) Receives a recommendation from a device classification 
panel (an FDA advisory committee); (2) publishes the panel's 
recommendation for comment, along with a proposed regulation 
classifying the device; and (3) publishes a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    A preamendments device that has been classified into class III and 
devices found substantially equivalent by means of premarket 
notification (510(k)) procedures to such a preamendments device or to a 
device within that type (both the preamendments and substantially 
equivalent devices are referred to as preamendments class III devices) 
may be marketed without submission of a PMA until FDA issues a final 
order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) 
requiring premarket approval. Section 515(b)(1) of the FD&C Act directs 
FDA to issue an order requiring premarket approval for a preamendments 
class III device.
    Section 515(f) of the FD&C Act provides an alternative pathway for 
meeting the premarket approval requirement. Under section 515(f), 
manufacturers may meet the premarket approval requirement if they file 
a notice of completion of a PDP approved under section 515(f)(4) of the 
FD&C Act and FDA declares the PDP completed under section 515(f)(6)(B) 
of the FD&C Act. Accordingly, the manufacturer of a preamendments class 
III device may comply with a call for PMAs by filing a PMA or a notice 
of completion of a PDP. In practice, however, the option of filing a 
notice of completion of a PDP has rarely been used. For simplicity, 
although the PDP option remains available to manufacturers in response 
to a final order under section 515(b) of

[[Page 66178]]

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. 112-144). Section 608(b) of 
FDASIA amended section 515(b) 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 515(b)(1) 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 513(b) 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 513(b) of the FD&C Act to discuss the 
classification of multiple use blood lancets for multiple patient use 
(Ref. 1). Although, to FDA's 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 515(b)(3) 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 classification panel 
described in section 513(b) 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 513(e) 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 501(f)(2)(B) of the FD&C Act (21 
U.S.C. 351(f)(2)(B)). 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 501(f)(2)(B) of the FD&C Act, 
then the device would be deemed adulterated under section 501(f) 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 comment's 
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 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 515(b) 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 
FDA's 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

[[Page 66179]]

substantial risk of illness or injury to support a ban.
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    \1\ See FDA's General and Plastic Surgery Devices Panel meeting 
transcript for the June 26, 2013, meeting (Ref. 1) discussion at 
page 104.
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III. The Final Order

    Under section 515(b)(3) 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 513(e) 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 FDA's 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 501(f)(1)(A) 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 515(d)(1)(B)(i) 
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 501(f)(1)(A) 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 met on or before May 
22, 2024. There will be no extended period for filing an IDE or 
exemption from the IDE requirements (see Sec.  812.2(d)), 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 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 
807, subpart E, unless the device is exempt from 510(k) because the 
applicable requirements of part 812, including obtaining IDE approval, 
are met.

IV. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) 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 515(b) 
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 515(b)(1) 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 25.34(b) 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 collections 
of information in 21 CFR part 814, subparts A through E, have been 
approved under OMB control number 0910-0231. The collections of 
information in part 807, subpart E, have been approved under OMB 
control number 0910-0120. The collections of information in 21 CFR part 
801 have been approved under OMB control number 0910-0485. The 
collections of information in part 812 have been approved under OMB 
control number 0910-0078.

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. FDA's 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/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM362831.pdf; and https://wayback.archive-it.org/7993/20170405193132/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/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 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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


0
2. In Sec.  878.4850, add paragraph (d)(3) to read as follows:


Sec.  878.4850  Blood lancets.

* * * * *
    (d) * * *

[[Page 66180]]

    (3) Date PMA or notice of completion of a PDP is required: A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before May 22, 2024, for any multiple use 
blood lancet for multiple patient use described in paragraph (d)(1) of 
this section that was in commercial distribution before May 28, 1976, 
or that has, on or before May 22, 2024, been found to be substantially 
equivalent to a multiple use blood lancet for multiple patient use 
described in paragraph (d)(1) of this section that was in commercial 
distribution before May 28, 1976. Any other multiple use blood lancet 
for multiple patient use shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25381 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P