Notice2021-27891
Transition Plan for Medical Devices Issued Emergency Use Authorizations During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health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 this transition process with respect to devices issued EUAs during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This draft guidance is not final nor is it in effect at this time.
Full Text
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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 72978-72981]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27891]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1149]
Transition Plan for Medical Devices Issued Emergency Use
Authorizations 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Emergency; Draft Guidance for Industry and Food and Drug Administration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 or Agency) is announcing
the availability of the draft guidance entitled ``Transition Plan for
Medical Devices Issued Emergency Use Authorizations (EUAs) 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
this transition process with respect to devices issued EUAs during the
COVID-19 PHE, including recommendations regarding submitting a
marketing submission, as applicable, and taking other actions with
respect to these devices. 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 proposed collection of information in the draft guidance 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-1149 for ``Transition Plan for Medical Devices Issued
Emergency Use Authorizations (EUAs) 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>.
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
[[Page 72979]]
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 Issued Emergency Use
Authorizations (EUAs) 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#19494b584a6d787f7f597f7d783771716a377e766f"><span class="__cf_email__" data-cfemail="b6e6e4f7e5c2d7d0d0f6d0d2d798dedec598d1d9c0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance applies to devices that have been issued EUA
under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360bbb-3) on the basis of a device-related COVID-19 EUA
declaration. This draft guidance does not apply to devices for which
FDA has revoked the EUA under section 564(g)(2)(B)-(C) of the FD&C Act
because the criteria under section 564(c) of the FD&C Act were no
longer met or because other circumstances made such revocation
appropriate to protect the public health or safety. FDA is concurrently
issuing a companion guidance to describe FDA's recommendations for
transitioning devices that fall within enforcement policies issued
during the COVID-19 PHE.
Given the magnitude of the COVID-19 PHE, FDA recognizes that some
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) under an EUA.
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 Issued Emergency Use Authorizations (EUAs)
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.
FDA is concurrently issuing a companion draft guidance to describe
FDA's recommendations for transitioning devices that fall within
enforcement policies issued during the COVID-19 PHE.
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 draft 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
Issued Emergency Use Authorizations (EUAs) During the COVID-19 Public
Health Emergency'' may send an email request to <a href="/cdn-cgi/l/email-protection#3d7e796f75107a4854595c535e587d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="84c7c0d6cca9c3f1ede0e5eae7e1c4e2e0e5aaececf7aae3ebf2">[email protected]</span></a> to receive an electronic copy of the document.
Please use the document number 21012 and complete title to identify the
draft 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 Issued Emergency Use Authorizations
(EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency OMB Control Number 0910-0595; Revision
The following paragraphs discuss the one-time burdens associated
with information collections found in the draft guidance, ``Transition
Plan for Medical Devices Issued Emergency Use Authorizations (EUAs)
During the 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, 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:
[[Page 72980]]
Table 1--Estimated One-Time Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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........................
Labeling mitigation for devices 340 1 340 1.25 425
under FDA review after the EUA
termination date...............
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Total....................... .............. .............. .............. .............. 1,418
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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.A 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 whether or not they intend to submit a marketing submission
to continue distributing their product after the EUA termination date.
The draft guidance recommends that manufacturers of such devices
include in this notification: (1) General information (e.g., contact
information); (2) the EUA request number; (3) a list of all model
numbers or other device identifying information; (4) whether the
manufacturer plans to submit a marketing submission; and (5) if not
planning to submit a marketing submission, the manufacturer should
discuss, as applicable, its plan to stop distribution of the device, to
restore the device to a previously FDA-cleared or approved version, 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 EUA termination date. The manufacturer should
submit this information designated with the EUA number as an ``EUA
report.'' FDA recommends that manufacturers notate the following on the
cover letter of the submission: ``Attention: Notification of Intent.''
Based on the current EUA submissions and authorizations, 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.B.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 an EUA currently in U.S.
distribution, and a benefit-risk based plan for disposition of
distributed product as detailed in the draft guidance.
Considering the current EUA submissions and authorizations, 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 two-
thirds of these products, or about 340 products. Based on the
recommended content of a transition plan, we estimate that the average
burden per response is 2 hours.
Labeling mitigation for reusable devices: The draft guidance
indicates that when manufacturers of certain reusable devices do not
intend to distribute their device beyond the EUA termination date, 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 EUA termination date 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, continuous renal
replacement therapy systems) that were distributed before the EUA
termination date remain distributed. Such devices should either be
restored by the manufacturer to the previously FDA-cleared or approved
version of the 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 estimate 170 respondents, which
is about one-third of devices currently under an EUA issued during the
COVID-19 PHE, will make such labeling available.
Labeling mitigation for devices under FDA review after the EUA
termination date: During the period after the EUA termination date, for
devices for which a marketing submission has been accepted by FDA but
before FDA has taken final action on the submission, labeling should be
updated to accurately state that the product was authorized under an
EUA issued during the COVID-19 PHE and remains under FDA review for
clearance or approval. We believe updating this labeling will also take
approximately 1 hour and 15 minutes per device. We estimate that the
majority of devices for which manufacturers pursue a marketing
submission may remain under FDA review for clearance or approval during
the period after the EUA termination date.
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 72981]]
Table 2--Guidances and Collections
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OMB Control
21 CFR part or guidance Topic No.
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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''.
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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 period proposed for advance notice of
termination of each EUA declaration pertaining to devices would
sufficiently allow for an appropriate transition period that avoids
exacerbating product shortages and supply chain disruptions.
2. Whether FDA's issuance of this draft guidance with a proposed
transition policy and requesting public comment may help the Agency to
satisfy, or otherwise determine how to best satisfy, while also
effectively managing Agency resources, the requirement in section
564(b)(2)(B) of the FD&C Act to consult with a manufacturer that was
issued an EUA for an unapproved product on the appropriate disposition
of the product.
Dated: December 20, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27891 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P
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