[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72973-72976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1118]


Transition Plan for Medical Devices That Fall Within Enforcement 
Policies Issued During the Coronavirus Disease 2019 Public Health 
Emergency; Draft Guidance for Industry and Food and Drug Administration 
Staff; Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of the draft guidance entitled ``Transition 
Plan for Medical Devices That Fall Within Enforcement Policies Issued 
During the Coronavirus Disease 2019 (COVID-19) Public Health 
Emergency.'' FDA recognizes that it will take time for device 
manufacturers, healthcare facilities, healthcare providers, patients, 
consumers, and FDA to adjust from policies adopted and operations 
implemented during the declared public health emergency (PHE) to normal 
operations. To provide a clear policy for all stakeholders and FDA 
staff, the Agency is issuing this guidance to describe FDA's general 
recommendations for a phased transition process with respect to devices 
that fall within enforcement policies issued during the COVID-19 PHE, 
including recommendations regarding submitting a marketing submission, 
as applicable, and taking other actions with respect to these devices. 
FDA is concurrently issuing a companion guidance to describe FDA's 
recommendations for this transition process with respect to devices 
issued Emergency Use Authorizations (EUAs) during the COVID-19 PHE. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by March 23, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit either electronic or written comments 
on the collection of information by February 22, 2022.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-D-1118 for ``Transition Plan for Medical Devices That Fall 
Within Enforcement Policies Issued During the Coronavirus Disease 2019 
(COVID-19) Public Health Emergency.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

[[Page 72974]]

    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Transition Plan for Medical Devices That Fall Within Enforcement 
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public 
Health Emergency'' to the Office of Policy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
request.

FOR FURTHER INFORMATION CONTACT: 
    With regard to the draft guidance: Joshua Silverstein, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 
301-796-5155; or Jacqueline Gertz, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1655, Silver Spring, MD 20993-0002, 240-402-9677.
    With regard to the proposed collection of information: Amber 
Sanford, Office of Operations, Food and Drug Administration, Three 
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-8867, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance applies to devices that fall within the enforcement 
policies described in List 1 of the draft guidance. FDA is concurrently 
issuing a companion guidance to describe FDA's recommendations for this 
transition process with respect to devices issued EUAs during the 
COVID-19 PHE.
    Given the magnitude of the COVID-19 PHE, FDA recognizes that 
continued flexibility, while still providing necessary oversight, will 
be appropriate to facilitate an orderly and transparent transition back 
to normal operations. Further, FDA is taking into account that the 
manufacture, distribution, and use of devices in the context of the 
COVID-19 PHE raises unique considerations. These unique considerations 
include, for example, the manufacturing of devices by non-traditional 
manufacturers to address supply issues and the distribution and use of 
capital or reusable equipment (e.g., ventilators, extracorporeal 
membrane oxygenation systems) that fall within enforcement policies.
    FDA is proposing a 180-day transition period that will begin on the 
implementation date and end on the date that the guidances in List 1 of 
the draft guidance are withdrawn. FDA requests public comment on this 
timeline from all interested stakeholders. FDA believes a phased 
approach over the course of 180 days following the implementation date 
as set forth in this guidance can help foster compliance with 
applicable statutory and regulatory requirements once the relevant 
enforcement policies are no longer in effect.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on Transition 
Plan for Medical Devices That Fall Within Enforcement Policies Issued 
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance is also 
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Transition Plan for Medical Devices 
That Fall Within Enforcement Policies Issued During the Coronavirus 
Disease 2019 (COVID-19) Public Health Emergency'' may send an email 
request to [email protected] to receive an electronic copy of 
the document. Please use the document number 21012 and complete title 
to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Transition Plan for Medical Devices That Fall Within Enforcement 
Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public 
Health Emergency

OMB Control Numbers 0910-0120 and 0910-0231--Revision

    The following paragraphs discuss the one-time burdens associated 
with information collections found in the draft guidance, ``Transition 
Plan for Medical Devices That Fall Within Enforcement Policies Issued 
During the Coronavirus Disease 2019 (COVID-19) Public Health 
Emergency.''
    The draft guidance is intended to help facilitate continued 
patient, consumer, and healthcare provider access to devices needed in 
the prevention,

[[Page 72975]]

treatment, and diagnosis of COVID-19. The information collections 
proposed in the draft guidance would assist the Agency in resource 
planning for marketing submission review and providing increased 
support to manufacturers. The information collections also include 
recommended information to provide in labeling for certain devices to 
inform potential users of the device's regulatory status, including 
physical labeling for life-supporting/life-sustaining devices.
    FDA estimates the burden of this collection of information as 
follows:

                                     Table 1--Estimated One-Time Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Notification of intent..........             100               1             100               1             100
Transition plan.................             340               1             340               2             680
Labeling mitigation for reusable             170               1             170            1.25             213
 devices........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             993
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Notification of intent: In Section V.C.(1) of the draft guidance, 
`` `Notifications of Intent' for Certain Reusable Life-Supporting or 
Life-Sustaining Devices,'' FDA recommends that manufacturers of certain 
life-supporting or life-sustaining devices submit to FDA information 
regarding their intent to submit a marketing submission or not. The 
guidance recommends that manufacturers of such devices include in this 
notification, general information (e.g., contact information); the 
title of the relevant enforcement policy guidance; submission number(s) 
for related premarket submissions; a list of all model numbers or other 
device identifying information; whether the manufacturer plans to 
submit a marketing submission; and, if not planning to submit a 
marketing submission, the manufacturer should discuss, as applicable, 
its plan to discontinue distribution of the device, to restore the 
device to a previously FDA-cleared or -approved version (if 
applicable), to provide a physical copy or electronic updated labeling, 
and any other efforts to address or mitigate potential risks of devices 
that remain distributed after the transition period has ended and the 
guidances in List 1 of the draft guidance have been withdrawn. If the 
device was previously FDA-cleared or -approved and a modified version 
was distributed as described in a policy in a guidance in List 1 of the 
draft guidance, the manufacturer should submit this information as a 
premarket notification (i.e., 510(k)) or premarket approval application 
(PMA) ``amendment'' to the manufacturer's existing device submission 
that was previously cleared or approved. FDA recommends that 
manufacturers notate the following on the cover letter of the 
submission: ``Attention: Notification of Intent''. Based on the number 
of devices that may be marketed under the immediately in effect 
guidance enforcement policies, we estimate we will receive 100 
notifications of intent for certain life-supporting or life-sustaining 
devices. Considering the recommended content of a notification, we 
estimate that the average burden per response is 1 hour.
    Transition implementation plan: Section V.D.1 of the draft guidance 
recommends that manufacturers who intend to continue distribution of 
their device include with their marketing submissions a ``transition 
implementation plan'' that addresses the manufacturers' plans for 
devices already distributed in the case of a positive decision or a 
negative decision on its marketing submission. The ``transition 
implementation plan'' should include information regarding the 
estimated number of devices distributed under the enforcement policy 
currently in U.S. distribution, and a benefit-risk based plan for 
disposition of distributed product as detailed in the draft guidance.
    Considering the amount of devices that may fall within enforcement 
policies, the amount of these products that are 510(k) exempt, and the 
amount of respondents we estimate are likely to pursue marketing 
submission, we estimate that we will receive transition plans for 
approximately 340 products. Based on the recommended content of a 
transition plan, we estimate that the average burden per response is 2 
hours.
    Labeling mitigation: The draft guidance indicates that when 
manufacturers of certain reusable devices do not intend to continue to 
distribute their devices beyond the transition period, FDA does not 
intend to object to the disposition of already distributed devices 
(i.e., FDA does not intend to request market removal), as detailed in 
the draft guidance.
    The draft guidance states that FDA does not intend to object to 
reusable, non-life-supporting/non-life-sustaining devices that were 
distributed before the withdrawal of the relevant guidance remaining 
distributed and being used by their end user. Such devices should 
either be restored by the manufacturer to the previously FDA-cleared or 
-approved version or have publicly available labeling that accurately 
describes the product features and regulatory status (i.e., that the 
product lacks FDA clearance or approval). In addition, the draft 
guidance recommends that reusable life-supporting/life-sustaining 
devices (e.g., ventilators, extracorporeal membrane oxygenation 
systems) that were distributed before the withdrawal of the relevant 
guidance remain distributed. Such devices should either be restored by 
the manufacturer to the previously FDA-cleared or -approved device, or 
have both publicly available and a physical copy of labeling that 
specifies that the device lacks FDA clearance or approval. We estimate 
that, on average, updating the labeling will take approximately 1 hour 
and 15 minutes. We believe these reusable devices represent about half 
of the marketing submissions (170).
    This draft guidance also refers to previously approved FDA 
collections of information. The collections of information in the 
following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

[[Page 72976]]



                   Table 2--Guidances and Collections
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                                                            OMB Control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
803............................  Medical Devices;              0910-0437
                                  Medical Device
                                  Reporting;
                                  Manufacturer
                                  reporting, importer
                                  reporting, user
                                  facility reporting,
                                  distributor reporting.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
807, subparts A through D......  Electronic Submission         0910-0625
                                  of Medical Device
                                  Registration and
                                  Listing.
806............................  Corrections and               0910-0359
                                  Removals.
830 and 801.20.................  Unique Device                 0910-0720
                                  Identification.
800, 801, and 809..............  Medical Device Labeling       0910-0485
``Emergency Use Authorization    Emergency Use                 0910-0595
 of Medical Products and          Authorization.
 Related Authorities''.
------------------------------------------------------------------------

IV. Other Issues for Consideration

    As discussed in the draft guidance, FDA understands that it will 
take time for device manufacturers, healthcare facilities, healthcare 
providers, patients, consumers, and FDA to adjust from policies adopted 
and operations implemented during the declared PHE to normal 
operations. FDA encourages all stakeholders to comment on the following 
topics:
    1. Whether the 180-day transition period before FDA withdraws the 
guidances identified in List 1 would sufficiently allow for an 
appropriate transition period that avoids exacerbating product 
shortages and supply chain disruptions.
    2. Suggestions to add or remove guidances documents to or from List 
1 of the draft guidance.
    3. FDA's proposal to extend the effectiveness of the guidances in 
List 1 of the draft guidance either for 180 days or for at least 225 
days, if the PHE declaration under section 319 of the Public Health 
Service Act expires before the finalization of this guidance.

    Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27892 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P


