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Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

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Published

December 23, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health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 This draft guidance is not final nor is it in effect at this time.

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<title>Federal Register, Volume 86 Issue 244 (Thursday, December 23, 2021)</title>
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[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72973-72976]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Emergency; Draft Guidance for Industry and Food and Drug Administration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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.

[[Page 72974]]

Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#d787859684a3b6b1b197b1b3b6f9bfbfa4f9b0b8a1"><span class="__cf_email__" data-cfemail="abfbf9eaf8dfcacdcdebcdcfca85c3c3d885ccc4dd">[email&#160;protected]</span></a>.

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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#cc8f889e84e18bb9a5a8ada2afa98caaa8ade2a4a4bfe2aba3ba"><span class="__cf_email__" data-cfemail="256661776d0862504c41444b4640654341440b4d4d560b424a53">[email&#160;protected]</span></a> 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
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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........................
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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

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