Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Contains Nonbinding Recommendations
Transition Plan for Medical Devices
Issued Emergency Use Authorizations
(EUAs) Related to Coronavirus
Disease 2019 (COVID-19)
Guidance for Industry, Other
Stakeholders, and Food and Drug
Administration Staff
Document issued on March 27, 2023.
The draft of this document was issued on December 23, 2021.
For questions about this document, contact the Regulation, Policy, and Guidance Staff at
RPG@fda.hhs.gov. For general questions about emergency use authorizations, contact the Office
of the Commissioner/Office of the Chief Scientist/Office of Counterterrorism and Emerging
Threats at AskMCMi@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
Identify all comments with the docket number FDA-2021-D-1149. Comments may not be acted
upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number
GUI00020042 and complete title of the guidance in the request.

Contains Nonbinding Recommendations
Table of Contents
I. Introduction ............................................................................................................................. 1
II. Background ............................................................................................................................. 2
III. Scope ....................................................................................................................................... 5
IV. Guiding Principles .................................................................................................................. 5
V. Transition Plan for Devices Authorized Under an EUA ........................................................ 6
A. “Notifications of Intent” for Certain Reusable Life-Supporting or Life-Sustaining
Devices ........................................................................................................................................ 8
B. Devices distributed after the EUA termination date ........................................................... 9
(1) Recommendations for “Transition Implementation Plan” ......................................... 10
(2) Enforcement policy for devices with a marketing submission under review by FDA 12
(3) Additional considerations for EUA-authorized in vitro diagnostics – Clinical
Laboratory Improvement Amendments of 1988 (CLIA) categorization and waivers .......... 14
C. Devices not distributed after the EUA termination date ................................................... 16
D. Discontinuing distribution of a device .............................................................................. 17
E. Quality System considerations .......................................................................................... 18
F. Laboratory developed tests (LDTs) .................................................................................. 18
VI. Examples ............................................................................................................................... 19
Example 1 ................................................................................................................................. 19
Example 2 ................................................................................................................................. 20
Example 3 ................................................................................................................................. 21
Example 4 ................................................................................................................................. 22

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1
Transition Plan for Medical Devices
Issued Emergency Use Authorizations
(EUAs) Related to Coronavirus
Disease 2019 (COVID-19)
Guidance for Industry, Other
Stakeholders, and Food and Drug
Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. 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. To discuss an alternative approach, contact the FDA staff
or Office responsible for this guidance as listed on the title page.
I. Introduction
FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging
infectious diseases, including Coronavirus Disease 2019 (COVID-19). FDA is committed to
providing timely guidance to support response efforts to the COVID-19 pandemic. FDA
recognizes that it will take time for device1 manufacturers,2 device distributors, healthcare
1 Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act provides that the term “device” means:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is—
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to
them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or
prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for the achievement of its primary intended
purposes. The term ‘device’ does not include software functions excluded pursuant to section 520(o)” of the
Federal Food, Drug and Cosmetic Act.
2 Throughout this guidance, when describing policies for devices that have been issued an emergency use
authorization, FDA uses the term “manufacturer” to refer to any person who designs, manufactures, fabricates,
assembles, or processes a finished device. See 21 CFR 820.3(o). Other entities, including those that introduce such
devices into commercial distribution, such as initial importers and certain distributors, should ensure they
understand, and where applicable they should follow, the recommendations that pertain to such devices.

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facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and
operations implemented during the COVID-19 pandemic to “normal operations.”3 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
emergency use authorizations (EUAs) related to COVID-19, including recommendations
regarding submitting a marketing submission, as applicable, and taking other actions with respect
to these devices.
FDA is concurrently issuing a companion transition guidance to describe FDA’s
recommendations for devices that fall within certain enforcement policies issued during the
COVID-19 public health emergency (PHE).4 FDA believes these transition guidances will help
prepare manufacturers and other stakeholders for the transition to normal operations and foster
compliance with applicable requirements under the FD&C Act and its implementing regulations.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. Background
In 2019, an outbreak of respiratory disease caused by a novel coronavirus began. The virus has
been named “SARS-CoV-2,” and the disease it causes has been named “Coronavirus Disease
2019” (COVID-19). On January 31, 2020, the Secretary of Health and Human Services (HHS)
issued a declaration of a PHE related to COVID-19 in accordance with section 319 of the Public
Health Service Act (PHS Act) and mobilized the Operating Divisions of HHS.5 In addition, on
March 13, 2020, the President declared a national emergency in response to COVID-19.6 On
February 9, 2023, the HHS Secretary renewed the section 319 PHE declaration related to
3 Throughout this guidance, FDA refers to “normal operations” as a shorthand for the circumstances when the
declaration of the public health emergency related to COVID-19 under section 319 of the Public Health Service Act
has expired and/or the relevant device emergency use declarations related to COVID-19 under section 564 of the
Federal Food, Drug, and Cosmetic Act are terminated.
4 The guidance “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policies-
issued-during-coronavirus-disease, will be referred to as the “companion transition guidance” in the remainder of
this guidance.
5 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued
on January 31, 2020, and subsequently renewed), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
6 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)
Outbreak (March 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-
declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021,
there was a Presidential Declaration continuing the national emergency concerning the COVID-19 pandemic beyond
March 1, 2021. See Continuation of the National Emergency Concerning the Coronavirus Disease 2019 (COVID-
19) Pandemic (86 FR 11599), available at https://www.federalregister.gov/documents/2021/02/26/2021-
04173/continuation-ofthe-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.

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COVID-19, effective February 11, 2023. The section 319 PHE declaration related to COVID-19
is anticipated to expire at the end of the day on May 11, 2023.7
FDA has authorized the emergency use of devices under section 564 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act).8 Section 564 of the FD&C Act authorizes FDA, after the HHS
Secretary has made a declaration of emergency or threat justifying authorization of emergency
use (an “EUA declaration”), to authorize the emergency use of an unapproved product9 or an
unapproved use of an approved product for certain emergency circumstances.10 FDA may issue
an EUA to allow a product to be used to diagnose, treat, or prevent a serious or life-threatening
disease or condition referenced in the EUA declaration, when the statutory criteria are met,
including FDA’s determination that, based on the totality of scientific evidence, the product may
be effective for such use, the known and potential benefits outweigh the known and potential
risks for such use, and that there are no adequate, approved, and available alternatives.11
An EUA issued under section 564 of the FD&C Act remains in effect for the duration of the
relevant EUA declaration, unless FDA chooses to revoke the EUA because the criteria for
issuance are no longer met or revocation is appropriate to protect public health or safety.12 An
EUA declaration under section 564 of the FD&C Act is distinct from, and is not dependent on,
a declaration by the HHS Secretary of a PHE under section 319 of the PHS Act.13 The device
7 See the HHS “Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap,” (February 9, 2023),
available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-
roadmap.html.
8 A list of all device EUAs related to COVID-19 is available at https://www.fda.gov/emergency-preparedness-and-
response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
9 Under sections 564(a)(2)(A) and 564(a)(4)(D) of the FD&C Act, an unapproved product is one that “is not
approved, licensed, or cleared for commercial distribution under section 505, 510(k), 512, or 515 of [the FD&C] Act
or section 351 of the [PHS] Act or conditionally approved under section 571 of [the FD&C] Act.”
10 Pursuant to section 564 of the FD&C Act, and on February 4, 2020, the HHS Secretary determined that there is a
public health emergency that has significant potential to affect national security or the health and security of U.S.
citizens living abroad, and that involves the SARS-CoV-2 virus that causes COVID-19. On the basis of such
determination, the HHS Secretary declared on that same day, that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or diagnosis of the SARS-CoV-2 virus that causes COVID-
19 (85 FR 7316), available at https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-
public-health-emergency. Based on the February 4, 2020 determination, the HHS Secretary issued two more
declarations justifying emergency uses related to devices: on March 2, 2020, for certain personal respiratory
protective devices (85 FR 13907), available at https://www.federalregister.gov/documents/2020/03/10/2020-
04823/emergency-use-declaration, and on March 24, 2020, for devices, including alternative products used as
devices (85 FR 17335), available at https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-
use-authorization-declaration, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section. On March 15, 2023, the HHS Secretary amended the February 4, 2020 determination to
recognize the fact that there is “a public health emergency, or a significant potential for a public health emergency,
that affects, or has a significant potential to affect, national security or the health and security of [U.S.] citizens
living abroad…” and that involves the SARS-CoV-2 virus that causes COVID-19 (emphasis added) (88 FR 16644),
available at https://www.federalregister.gov/documents/2023/03/20/2023-05609/covid-19-emergency-use-
authorization-declaration.
11 For more information on FDA’s emergency use authorities under section 564 of the FD&C Act, see the guidance
“Emergency Use Authorization of Medical Products and Related Authorities” (“EUA Guidance”), available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-
products-and-related-authorities.
12 See sections 564(f)-(g) of the FD&C Act.
13 For additional information on this topic, see FDA’s EUA Guidance, at p. 5, footnotes 12 and 15.

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EUAs related to COVID-19 remain in effect until the relevant EUA declaration under section
564 of the FD&C Act is terminated or FDA otherwise revokes a specific EUA,14 even if the
section 319 PHE declaration related to COVID-19 expires before then.15
Given the magnitude of the response to the COVID-19 pandemic, including the number of
devices issued EUAs, FDA recognizes that stakeholders may need time to adjust after the
termination of the device EUA declarations to help ensure an orderly and transparent
transition to normal operations. Further, FDA is taking into account that the manufacture,
distribution, and use of devices in the context of the COVID-19 pandemic 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 EUAs.
FDA developed this guidance to describe a transition plan, among other things, to help avoid
disruption in device supply and help facilitate compliance with applicable FD&C Act
requirements after the termination of the relevant EUA declaration related to COVID-19
under section 564(b) of the FD&C Act.
Section 564 of the FD&C Act provides a statutory framework describing the circumstances in
which an EUA declaration shall terminate and the process for such termination.16 Under section
564(b) of the FD&C Act, the HHS Secretary is required to provide advance notice that an EUA
declaration will be terminated and to publish such notice in the Federal Register.17 When an
EUA declaration is terminated, all EUAs issued under that declaration also terminate. After an
EUA declaration terminates, it ceases to be in effect and the emergency use of all products under
the EUA declaration are no longer authorized.
Pursuant to section 564(b)(2)(B) of the FD&C Act, when an EUA for an unapproved product
ceases to be effective as a result of the termination of an EUA declaration, FDA must consult
with the manufacturer of such product with respect to the appropriate disposition of the product.
FDA believes that by issuing this guidance in draft with a proposed transition policy and
requesting public comment (including from manufacturers of EUA-authorized devices), the
Agency has satisfied the requirement to consult with manufacturers, while also efficiently
managing Agency resources. To address any unique considerations or other issues related to
disposition of product that are not otherwise discussed in this guidance, FDA recommends
engagement with the Agency as soon as possible.18
14 See sections 564(f)-(g) of the FD&C Act.
15 See the HHS “Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap,” (February 9, 2023),
available at https://www.hhs.gov/about/news/2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-
roadmap.html.
16 Section 564(b)(2) of the FD&C Act.
17 Sections 564(b)(3) and (4) of the FD&C Act.
18 FDA recommends that manufacturers engage with the Agency through the Q-Submission Program, including
requesting feedback in Pre-Submissions, to discuss the appropriate disposition of their product. For details on the Q-
Submission Program, refer to the guidance “Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program.

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HHS intends to publish the advance notice of termination of each EUA declaration19 pertaining
to devices in the Federal Register 180 days before the day on which the EUA declaration is
terminated. The advance notice of termination of each device EUA declaration may occur
simultaneously or at different times, depending on whether the circumstances underlying such
declarations continue to exist.20 For purposes of this guidance, FDA refers to the date on which
an EUA is terminated as the “EUA termination date.” During the time between the advance
notice of termination of an EUA declaration and the EUA termination date, manufacturers of
devices with EUAs issued pursuant to such an EUA declaration and others21 must continue to
comply with the terms of the devices’ respective EUAs, including applicable conditions of
authorization22 identified in the EUA letters of authorization for the devices.
FDA recommends that manufacturers of devices authorized under EUAs plan their post-EUA
regulatory and disposition strategies now. When an EUA declaration is terminated, the Agency
intends to promptly publish notice of termination of the associated EUAs in the Federal Register
and an explanation of the reasons for the termination.23
III. Scope
This guidance applies to devices that have been issued an EUA under section 564 of the FD&C
Act on the basis of a device EUA declaration related to COVID-19.24
Current good manufacturing practice deviations authorized under section 564A(c) of the FD&C
Act are outside the scope of this guidance.
This 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.
IV. Guiding Principles
In developing this guidance, and its companion transition guidance regarding devices that fall
within certain enforcement policies issued during the COVID-19 PHE, several guiding principles
were followed. Some derive from existing policies and are widely known, and others are key to
understanding the approach set forth in this guidance. Thus, anyone using this guidance should
bear in mind the following guiding principles:
19 See footnote 10.
20 See section 564(b)(2)(A) of the FD&C Act.
21 Certain EUAs include conditions of authorization for parties other than the manufacturer, such as healthcare
facilities or distributors.
22 See section 564(e) of the FD&C Act.
23 See section 564(h)(1) of the FD&C Act.
24 See footnote 10.

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· This 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.
· FDA believes the policies and recommendations in this guidance will help to ensure an
orderly and transparent transition for devices that fall within the scope of this guidance.
FDA’s policies and recommendations in this guidance are consistent with the Agency’s
statutory mission to both protect and promote the public health.25
· FDA’s policies and recommendations follow, among other things, a risk-based approach
with consideration of differences in the intended use and regulatory history of devices,
including whether the device is life-supporting or life-sustaining,26 capital or reusable27
equipment, a single-use device,28 and whether another version of the device is FDA-
cleared or -approved.
· As always, FDA will make case-by-case decisions regarding the enforcement of legal
requirements in response to particular circumstances and questions that arise regarding a
specific device or device type. This may include FDA revising or revoking an EUA,29
requesting a firm initiate a recall (see 21 CFR 7.45),30 or taking other actions, including
an enforcement action. Moreover, FDA may revise the enforcement policies and
recommendations in the guidance, as appropriate.
V. Transition Plan for Devices Authorized Under an EUA
As previously stated, FDA recognizes that it will take time for device manufacturers, device
distributors, healthcare facilities, healthcare providers, patients, consumers, and the Agency to
adjust from policies adopted and operations implemented during the COVID-19 pandemic to
normal operations. FDA seeks to encourage and facilitate an appropriate transition period to
help, among other things, avoid exacerbating product shortages and supply chain disruptions.
This transition plan takes into account the advance notice(s) of termination of the EUA
declarations pertaining to devices, and the discussion below contains recommendations regarding
the preparation and submission of marketing submissions (including the timing of such
25 See section 1003(b) of the FD&C Act.
26 Life-supporting or life-sustaining devices are defined in 21 CFR 860.3. A list of life-supporting or life-sustaining
devices can be found by searching FDA’s product classification database:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
27 A reusable device is intended for repeated use either on the same or different patients, with appropriate cleaning
and other reprocessing between uses. For additional information see the guidance “Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling” available at https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-
and-labeling.
28 A single-use device is a device that is intended for one use or on a single patient during a single procedure. For
additional information see the guidance “Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling.”
29 See sections 564(f)-(g) of the FD&C Act.
30 21 CFR 7.45(a) states that FDA “may request a firm to initiate a recall when the following determinations have
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect
the public health and welfare.”

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submissions),31 manufacturers’ actions if they do not wish to continue distributing their product
after the EUA termination date, and the distribution of devices within the scope of this guidance.
For purposes of this guidance, devices are considered to be “already distributed” if they are
finished devices32 that are labeled and are in distribution33 in the U.S. supply chain or are in the
possession of the end user. For purposes of this guidance, FDA would generally consider devices
to be “in distribution” to mean those finished, labeled devices that are no longer in the
manufacturer’s possession that are in transit to or held in a third party’s device inventory not on
behalf of the manufacturer, in a federal, state, or other governmental stockpile, or at a location
where devices are then offered for direct sale to the end user.
During the time between the advance notice of termination of an EUA declaration and the EUA
termination date, manufacturers of devices with EUAs issued pursuant to such an EUA
declaration and others34 must continue to comply with the terms of the devices’ respective
EUAs, including applicable conditions of authorization35 identified in the EUA letters of
authorization for the devices.
FDA understands that there may be scenarios that are not specifically addressed in this guidance,
but generally believes that the policies and recommendations described, regardless of the specific
scenario for a manufacturer, will help avoid disruptions in critical devices and allow FDA to best
manage its resources for review of marketing submissions. To address any unique considerations
or other issues not otherwise discussed in this guidance, manufacturers may wish to initiate
discussions with the Agency through the Q-Submission Program, including requesting feedback
in Pre-Submissions. Manufacturers should submit any Pre-Submissions with the understanding
that their device will no longer be authorized for emergency use beginning on the EUA
termination date. If the manufacturer’s intent is to continue to distribute its device after the EUA
declaration for the device has been terminated, the manufacturer should promptly start preparing,
and FDA intends to help facilitate acceptance of, a marketing submission before the EUA
termination date. For details on the Q-Submission Program, refer to the guidance “Requests for
Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.”36
31 For purposes of this guidance, “marketing submission” means a premarket approval application (PMA), PMA
supplement, premarket notification (510(k)) submission, humanitarian device exemption (HDE) application, or De
Novo classification request (De Novo). For devices that are class I or II and exempt from premarket notification
(e.g., shoe covers, face shields), no 510(k) submission is required unless the limitations of exemption are exceeded
(see, e.g., 21 CFR 878.9).
32 See 21 CFR 820.3(l).
33 See 21 CFR 807.3(b) (defining “commercial distribution”).
34 Certain EUAs include conditions of authorization for parties other than the manufacturer, such as healthcare
facilities or distributors.
35 See section 564(e) of the FD&C Act.
36 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.

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A. “Notifications of Intent” for Certain Reusable Life
Supporting or Life Sustaining Devices
Given the public health significance of certain reusable life-supporting or life-sustaining devices
that have been issued an EUA, FDA requests that manufacturers of such devices submit to FDA
information regarding whether or not they intend to submit a marketing submission to FDA and
continue distributing their product after the EUA termination date. This information will assist
the Agency in resource planning for marketing submission review and providing support to
manufacturers. This request applies to EUA-authorized devices with a product code listed in
Table 1:
Table 1
Product Code Device Type Classification
Regulation
BSZ Gas-machine, anesthesia 21 CFR 868.5160
CAW Generator, oxygen, portable 21 CFR 868.5440
BTT Humidifier, respiratory gas, (direct
patient interface) 21 CFR 868.5450
QAV High flow/high velocity humidified
oxygen delivery device 21 CFR 868.5454
CBK Ventilator, continuous, facility use
21 CFR 868.5895
MNT Ventilator, continuous, minimal
ventilatory support, facility use
NOU Continuous, ventilator, home use
MNS Ventilator, continuous, non-life-
supporting
ONZ Mechanical ventilator
BTL Ventilator, emergency, powered
(resuscitator) 21 CFR 868.5925
QOO Ventilator tubing and accessories No corresponding
CFR section
Manufacturers of the devices identified in Table 1 should submit the following information to the
CDRH Document Control Center37 as soon as possible after issuance of this guidance:38
37 The mailing address for the CDRH Document Control Center can be found in 21 CFR 807.90(a)(1) and
814.104(d)(1). FDA encourages manufacturers to submit Notifications of Intent as eCopies. Information about the
eCopy program can be found in the guidance “eCopy Program for Medical Device Submissions,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-
submissions.
38 Submitting this information as soon as possible after issuance of this guidance is encouraged because it will assist
the Agency in resource planning, help to avoid any supply disruptions, and otherwise help to ensure a smooth

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· General information about the manufacturer, including contact information, name and
place of business, and email address;
· EUA request number;
· 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 plans to discontinue distribution of the device, to restore the device to an
FDA-cleared or -approved version, to provide a physical copy and/or electronic copy of
updated labeling, and any other efforts to address or mitigate potential risks of devices
already distributed as of the EUA termination date.
The manufacturer should submit this information designated with the EUA request number as an
“EUA report.” FDA recommends that manufacturers notate the following on the cover letter of
the submission: “Attention: Notification of Intent.” To the extent the Notification of Intent
contains trade secret information or confidential commercial or financial information, FDA will
handle that information in accordance with applicable laws, including 21 CFR 20.61.
B. Devices distributed after the EUA termination date
For manufacturers of devices authorized under an EUA seeking the required marketing
authorization39 for their devices, please refer to the recommendations and policies in the
subsections below. FDA recommends that these manufacturers submit their marketing
submissions to FDA with sufficient time for the submission to be accepted by FDA40 before the
EUA termination date. The marketing submission should be administratively complete in that it
includes all of the information necessary for FDA to conduct a substantive review.41 FDA
understands there may be extenuating circumstances that may make doing so difficult (e.g.,
ongoing clinical trial or longer term non-clinical studies). Manufacturers in such circumstances
should engage with the Agency early in the transition period.42
transition for these devices after the EUA termination date. If this information is submitted after publication of the
advance notice of termination of the EUA declaration, FDA recommends submission within 90 days of that
publication.
39 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
40 For more information regarding FDA’s acceptance policies for marketing submissions, see the guidances “Refuse
to Accept Policy for 510(k)s,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/refuse-accept-policy-510ks, “Acceptance and Filing Reviews for Premarket Approval Applications
(PMAs),” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-and-
filing-reviews-premarket-approval-applications-pmas, and “Acceptance Review for De Novo Classification
Requests,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-
review-de-novo-classification-requests.
41 See footnote 40.
42 FDA recommends that manufacturers engage with the Agency through the Q-Submission Program, including
requesting Pre-Submissions, to discuss extenuating circumstances. For details on the Q-Submission Program, refer
to the guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program.”

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FDA is taking into account that the use of devices during the COVID-19 pandemic may allow
manufacturers to utilize a variety of data sources in their marketing submission. As such, FDA
anticipates many manufacturers may wish to reference data from related marketing
authorizations and submissions, and use real-world data obtained as a result of device use during
the COVID-19 pandemic.43 FDA recommends that marketing submissions include in the cover
letter a statement that the device is/was previously authorized under an EUA and the EUA
request number, as well as submission number(s) for related premarket submissions. This
information will help FDA track devices that are transitioning from an EUA to the required
marketing authorization,44 facilitate review of the submission, and help ensure that transitioning
devices can be appropriately considered in light of the policy described in Section V.B.(2) of this
guidance.
(1) Recommendations for “Transition Implementation Plan”
FDA anticipates that some marketing submissions will include changes or updates to the device
and/or its labeling compared to the product that has been distributed under the EUA. For
example, a manufacturer may have distributed a singleplex in vitro diagnostic assay under an
EUA, and the manufacturer intends to submit a marketing submission for a multiplex in vitro
diagnostic assay; or a manufacturer may have distributed a remote monitoring device under an
EUA, and the manufacturer intends to submit a marketing submission for such remote
monitoring device with an additional, new indication. In addition, in some cases, a manufacturer
may not receive a positive decision from FDA on its marketing submission.
To help address all of these situations efficiently, FDA recommends that manufacturers include
in the cover letter of their marketing submission a “Transition Implementation Plan” that
addresses the manufacturers’ plans for dealing with devices already distributed in the case of a
positive decision as well as in the case of a negative decision on the marketing submission. To
the extent the Transition Implementation Plan contains trade secret information or confidential
commercial or financial information, FDA will handle that information in accordance with
applicable laws, including 21 CFR 20.61.
FDA recommends that the Transition Implementation Plan include the following information, as
applicable:45
· Estimated number of devices under an EUA that are currently in U.S. distribution;
· An explanation of the manufacturer’s benefit-risk based plan for disposition of already
distributed product in the event of a negative decision on the marketing submission. If the
manufacturer is proposing to leave already distributed product in place, the plan should
43 Data derived from real-world sources may be submitted in support of a marketing submission. See the guidance
titled “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-
regulatory-decision-making-medical-devices.
44 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
45 If the manufacturer has already submitted a Notification of Intent with some of this information, FDA still
recommends that manufacturers include a Transition Implementation Plan with their marketing submission, noting
any updates since the Notification of Intent was submitted to FDA.

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address the rationale for doing so and considerations such as the following, where
relevant:46
o Process for notifying patients, consumers, healthcare facilities, healthcare
providers, and device distributors of the device’s regulatory status;
o Process and timeline for restoring already distributed devices to an FDA-cleared
or -approved version;
o Process and timeline for providing47 a physical and/or electronic copy of updated
labeling that accurately describes the product features and regulatory status (e.g.,
that the product lacks FDA clearance, approval, or authorization) for reusable
devices. To help ensure accessibility to updated labeling for reusable life-
supporting/life-sustaining devices, FDA recommends that stakeholders be
provided an opportunity to request a physical copy of updated labeling, and after
such request, be provided the requested labeling without additional cost; and
o A description of the maintenance plan for already distributed devices.
· An explanation of the manufacturer’s plans for addressing already distributed product in
the event of a positive decision on the marketing submission, including considerations
such as the following, where relevant:
o Process for notifying patients, consumers, healthcare facilities, healthcare
providers, and device distributors of the device’s regulatory status; and
o Process and timeline for providing to users of already distributed devices updated
labeling or components for the cleared or approved device, including updated
labeling or components to reflect any cleared/approved changes to the already
distributed device.
FDA encourages manufacturers to collaborate with device distributors, healthcare facilities,
healthcare providers, patients, and consumers, as appropriate, regarding their Transition
Implementation Plan to assist all stakeholders with transition planning.
Depending on FDA’s evaluation of the marketing submission, FDA may engage with the
manufacturer during the Agency’s review of the submission to discuss the appropriate
disposition of already distributed devices described in the Transition Implementation Plan. For
marketing submissions that include changes to the device compared to the product that has been
distributed under the EUA (e.g., modifications to address a cybersecurity concern), the
manufacturer should discuss possible correction or removal with FDA regarding devices already
distributed to the end user, as needed. As always, FDA will make case-by-case decisions
regarding the enforcement of legal requirements in response to particular circumstances and
46 While FDA recommends that a benefit-risk based plan for disposition of already distributed product be included
with a marketing submission for devices within the scope of this guidance, FDA also believes such an approach is
consistent with device end-of-life best practices and recommends that manufacturers consider and conduct such
activities even if the manufacturer’s Transition Implementation Plan is not prospectively shared with the Agency.
47 The manufacturer should provide labeling to the original purchaser, and collaborate with the original purchaser to
ensure that labeling is distributed to relevant stakeholders, including device distributors, healthcare facilities,
healthcare providers, patients, consumers, etc.

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questions that arise regarding a specific device or device type (e.g., requesting a firm initiate a
recall (see 21 CFR 7.45)48 or taking other actions, including an enforcement action).
(2) Enforcement policy for devices with a marketing
submission under review by FDA
As previously stated, FDA recognizes that it may take time for device manufacturers, including
non-traditional device manufacturers, to adapt and adjust from their operations during the
COVID-19 pandemic to normal operations. As such, at this time, FDA does not intend to object
to the continued distribution of devices within the scope of this guidance after the EUA
termination date where:
· The manufacturer has submitted a marketing submission49 to FDA and it is accepted50 by
FDA before the EUA termination date; and
· FDA has not taken a final action51 on the marketing submission.
For these same devices, while the device is under FDA review, FDA does not intend to object to
the devices not bearing a Unique Device Identification (UDI) (see 21 CFR Part 801 Subpart B
and Part 830) or complying with other applicable labeling requirements (see 21 CFR Part 801)
where the device continues to be labeled as previously authorized under the EUA.52 As always,
FDA will make case-by-case decisions regarding the enforcement of legal requirements in
response to particular circumstances and questions that arise regarding a specific device or
device type.
The enforcement policy in this section (Section V.B.(2)) relates to FDA marketing authorization
(e.g., 510(k) clearance), UDI, and certain labeling requirements. It does not apply to other legal
48 21 CFR 7.45(a) states that FDA “may request a firm to initiate a recall when the following determinations have
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect
the public health and welfare.”
49 This includes a marketing submission for the device distributed under the EUA, or a marketing submission for a
device that is a derivative of, or the next generation of, the device distributed under the EUA.
50 Manufacturers that do not have an accepted marketing submission before the EUA termination date should refer
to the policy described in Section V.C. of this guidance.
51 For purposes of this guidance, FDA uses the term “final action” to mean a Medical Device User Fee Amendments
(MDUFA) decision, which can include positive decisions, negative decisions, and notices of withdrawals, consistent
with the: 510(k) Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clock-
and-goals; De Novo Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals;
and PMA Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/fda-and-industry-actions-premarket-approval-applications-pmas-effect-fda-review-clock-and-goals.
52 Based on comments received on this draft guidance, as well as the companion transition guidance, FDA
understands that updating the labeling of these devices while they are under FDA review, and then again if they are
subsequently cleared, approved, or authorized, would be challenging for manufacturers. This policy takes those
comments into account and is least burdensome for manufacturers and FDA. As noted elsewhere, manufacturers
should engage with the Agency if they have questions specific to their device (e.g., regarding updating the device
labeling to acknowledge that the device is currently under FDA review when the FDA review is expected to take an
extended period of time).

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requirements (such as registration and listing,53 Quality System (QS), and reports of corrections
and removals requirements under 21 CFR Parts 807, 820, and 806, respectively) that may apply
after the EUA termination date.54 Moreover, it does not apply after FDA has taken a final action
on the marketing submission for a device. At that time, FDA expects manufacturers to comply
with all applicable regulatory requirements for the device/manufacturer. Following the device’s
marketing authorization, this includes labeling updates (see 21 CFR Part 801), compliance with
UDI requirements (see 21 CFR Part 801 Subpart B and Part 830), and any applicable updates to
registration and listing information, including the submission number (see 21 CFR Part 807
Subparts B-D). After marketing authorization, manufacturers also should follow the steps
outlined in their Transition Implementation Plan.
In addition, and as always, FDA will make case-by-case decisions regarding the enforcement of
legal requirements in response to particular circumstances and questions that arise regarding a
specific device or device type. This may include FDA revising or revoking an EUA,55 requesting
a firm initiate a recall (see 21 CFR 7.45),56 or taking other actions, including an enforcement
action. Moreover, FDA may revise the enforcement policies and recommendations in the
guidance, as appropriate.
As mentioned previously, FDA recommends that marketing submissions include in the cover
letter a statement that the device is/was previously authorized under an EUA and the EUA
request number, as well as submission number(s) for related premarket submissions. This
information will help FDA track devices that are transitioning from an EUA to the required
marketing authorization,57 facilitate review of the submission, and help ensure that transitioning
devices can be appropriately considered in light of the policy described in this section (Section
V.B.(2) of this guidance).
In addition, during this transition period and after the EUA termination date, FDA may receive
questions from stakeholders (e.g., other Agencies, governmental stockpilers, healthcare
providers) about a device’s regulatory status for devices distributed as described in this section
(Section V.B.(2)) while the marketing submission is under review by FDA. Typically, if a device
53 For manufacturers that register and list by the EUA termination date, FDA recommends that manufacturers utilize
the term “emergency” (as a shorthand for “emergency use authorization”) in the premarket submission field if a
submission number is not yet available. If the device subsequently receives marketing authorization, FDA expects
manufacturers to comply with all applicable registration and listing requirements, which may require updating the
listing information.
54 For more information regarding FDA regulatory requirements for a specific device and FDA policies related to
those requirements, manufacturers can use the FDA Guidance Search Tool to identify relevant guidances
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/). Following the EUA termination
date, FDA will look to any other applicable compliance policies and otherwise apply our general risk-based
approach in making compliance and enforcement decisions. For more information, see the guidance “Factors to
Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement
Decisions,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-
consider-regarding-benefit-risk-medical-device-product-availability-compliance-and.
55 See sections 564(f)-(g) of the FD&C Act.
56 21 CFR 7.45(a) states that FDA “may request a firm to initiate a recall when the following determinations have
been made: (1) That a product that has been distributed presents a risk of illness or injury or gross consumer
deception. (2) That the firm has not initiated a recall of the product. (3) That an agency action is necessary to protect
the public health and welfare.”
57 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.

Contains Nonbinding Recommendations
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has an EUA or conventional marketing authorization (e.g., 510(k) clearance), this information
would be publicly available. The existence of a marketing submission under review is not
typically disclosed unless certain circumstances apply, such as when the device is on the
market.58 As such, for devices distributed as described in this section, FDA may share that a
manufacturer is distributing such device as described in the policy in this guidance, which could
indirectly reveal that the manufacturer has a marketing submission under review by FDA.59
(3) Additional considerations for EUA-authorized in vitro
diagnostics – Clinical Laboratory Improvement
Amendments of 1988 (CLIA) categorization and waivers
In vitro diagnostics (IVDs) authorized under an EUA are generally authorized for use in specific
settings, such as those certified as laboratories under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA),60 that meet the requirements to perform high or moderate
complexity tests, or for use at the point-of-care (POC), i.e., in patient care settings operating
under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
FDA’s determination that an EUA-authorized IVD is deemed to be in a particular category of
examinations and procedures under CLIA is effective only while the relevant declaration under
section 564(b) of the FD&C Act is in effect.61 Outside of EUAs, CLIA categorization typically is
determined by FDA after FDA has cleared or approved a marketing submission.62 Prior to a
categorization as moderate complexity or waived, an IVD is considered to be high complexity
and, under CLIA, use of that test is limited to laboratories that are certified under CLIA, and that
meet the requirements to perform tests of high complexity.
For IVDs authorized under an EUA for use in laboratories certified under CLIA that meet the
requirements to perform moderate complexity tests, FDA intends to categorize the test’s
complexity immediately following FDA’s final action on the marketing submission, per FDA’s
typical categorization process.
For IVDs authorized under an EUA for use in patient care settings operating under a CLIA
Certificate of Waiver, FDA intends to accept marketing submissions under the Dual 510(k) and
CLIA Waiver by Application pathway, or Dual De Novo and CLIA Waiver marketing
submissions63 modeled after the 510(k) and CLIA Waiver by Application pathway, as
58 See, e.g., 21 CFR 807.95(a)(1).
59 To the extent the marketing submission contains trade secret information or confidential commercial or financial
information, FDA will handle that information in accordance with applicable laws, including 21 CFR 20.61.
60 42 U.S.C. 263a.
61 See section 564(m)(3) of the FD&C Act.
62 See the FDA website for additional information on CLIA categorizations and FDA’s process, available at
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations.
63 Section 3301 of the Food and Drug Omnibus Reform Act of 2022, Title III of Division FF of the Consolidated
Appropriations Act, 2023, Pub. L. No. 117-328 (“FDORA”), amended section 513 of the FD&C Act to add
subsection (k), which states “[f]or a device authorized for emergency use under section 564 for which, in accordance
with section 564(m), the Secretary has deemed a laboratory examination or procedure associated with such device to
be in the category of examinations and procedures described in section 353(d)(3) of the Public Health Service Act,
the sponsor of such device may, when submitting a request for classification under section 513(f)(2), submit a single

Contains Nonbinding Recommendations
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appropriate. Manufacturers intending to submit a Dual Submission are encouraged to consider
the recommendations in the guidance “Recommendations for Dual 510(k) and CLIA Waiver by
Application Studies,”64 for information on the process and content of Dual Submissions.
Consistent with the recommendations in that guidance, data regarding actual use of the IVDs in
CLIA-waived settings for comparison and reproducibility studies will be helpful in making a
CLIA waiver determination. FDA anticipates that, in many cases, manufacturers will be able to
reference data from related marketing authorizations and submissions, including the EUA
request, and real-world data obtained as a result of use of the IVD under the EUA may be
submitted in support of a CLIA Waiver by Application. As described in the guidance
“Recommendations for Dual 510(k) and CLIA Waiver by Application Studies,” FDA
recommends submitting a Pre-Submission65 to discuss planned study designs for comparison and
reproducibility studies that support the marketing submission and the CLIA waiver, and the Dual
Submission should be submitted following a Pre-Submission.
For IVDs authorized under an EUA for home use, if a marketing submission for such test is
subsequently cleared, approved, or authorized for home use, the test will be waived by regulation
under 42 CFR 493.15(c), meaning that the test will be categorized as waived without the need for
a CLIA Waiver by Application.
FDA recommends that any marketing submission that may necessitate a CLIA categorization
decision (e.g., tests intended for use in moderate complexity laboratories or in CLIA Certificate
of Waiver settings) be submitted as soon as possible to facilitate FDA’s review of the marketing
submission and CLIA categorization request (or CLIA Waiver by Application) prior to the
termination of the EUA declaration to reduce the potential for disruption in distribution and use.
For IVDs authorized under an EUA for use in high complexity, moderate complexity, and
waived settings where, as described in Section V.B.(2) of this guidance, the manufacturer has
submitted a marketing submission to FDA and it is accepted by FDA before the EUA
termination date, and FDA has not taken a final action on the marketing submission or made a
determination on CLIA categorization, at this time, FDA does not intend to object to the
continued distribution and use of such tests consistent with the policy described in Section
V.B.(2) of this guidance and in a manner consistent with the EUA that was in effect prior to the
EUA termination date.66
submission containing -- (1) the information needed for such a request; and (2) sufficient information to enable the
Secretary to determine whether such laboratory examination or procedure satisfies the criteria to be categorized
under section 353(d)(3) of the Public Health Service Act.”
64 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-dual-
510k-and-clia-waiver-application-studies.
65 For details on the Q-Submission Program, refer to the guidance “Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program.”
66 Laboratories using such tests should consider whether CLIA requirements administered by the Centers for
Medicare & Medicaid Services (CMS) may apply.

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C. Devices not distributed after the EUA termination date
When a manufacturer does not intend to continue to distribute its device beyond the EUA
termination date, at this time, FDA does not intend to object to the disposition and use67 of
already distributed devices (i.e., FDA does not intend to request market removal68) as follows:
1) Single-use, non-life-supporting/non-life-sustaining devices (e.g., face masks), including
IVDs, that were distributed before the EUA termination date are used by the end user
prior to the product expiration date,69 as applicable.
2) Reusable, non-life-supporting/non-life-sustaining devices (e.g., non-invasive remote
patient monitoring devices) that were distributed before the EUA termination date are
used by their end user and either:
a. Are restored70 by the manufacturer to an FDA-cleared or -approved version of the
device,71 or
b. Have72 a physical and/or electronic copy of updated labeling that accurately
describes the product features and regulatory status (e.g., that the product lacks
FDA clearance, approval, or authorization).
3) 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 are restored73 by the manufacturer to an
FDA-cleared or -approved version of the device74 so that they may be used by their end
user. If not restored, a physical and/or electronic copy of updated labeling that accurately
describes the product features and regulatory status (e.g., that the product lacks FDA
clearance, approval, or authorization) should be provided,75 and such devices are not to
be used.76,77 To help ensure accessibility to updated labeling, FDA recommends that
stakeholders be provided an opportunity to request a physical copy of updated labeling,
and after such request, be provided the requested labeling without additional cost.
67 FDA recognizes that not all use would necessarily be violative (see, e.g., section 564(f)(2) of the FD&C Act). To
the extent such use is violative, FDA generally does not intend to object as described herein.
68 FDA uses the term “removal” consistent with the definition in 21 CFR 806.2(j).
69 For IVDs that were authorized under EUA, this is the product expiration date listed as of the EUA termination
date. Extension of the expiration date cannot be authorized after the EUA is terminated.
70 In situations where manufacturers do not believe restoration is possible or in the best interest of public health,
FDA recommends additional engagement with the Agency on the appropriate disposition of a product if it is not
otherwise discussed in this guidance.
71 For example, an FDA-cleared or -approved version may include an earlier software version, component
replacement, or different labeling that removes information related to the use of the device under the EUA.
72 The manufacturer should provide labeling to the original purchaser, and collaborate with the original purchaser to
ensure that labeling is distributed to relevant stakeholders, including device distributors, healthcare facilities,
healthcare providers, patients, consumers, etc.
73 See footnote 70.
74 See footnote 71.
75 See footnote 72.
76 FDA recognizes that not all use would necessarily be violative (see, e.g., section 564(f)(2) of the FD&C Act).
77 Should healthcare facilities wish to retain a device that lacks FDA clearance, approval, or authorization for use in
the future, the future use of the device would be subject to the regulatory requirements of any future authorization,
including marketing authorization or EUA, as applicable. For governmental stockpilers that wish to retain a device
that lacks requisite FDA clearance, approval, or authorization for use in the future, FDA recommends engaging with
the Agency to discuss the public health need for future deployment and/or use of the device in specific
circumstances (e.g., regional natural disaster, localized disease outbreaks).

Contains Nonbinding Recommendations
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Manufacturers that do not intend to distribute their devices after the EUA termination date
should also refer to relevant information included in this guidance in other sections (though note
that recommendations in Section V.B. are intended only for manufacturers that intend to
distribute their device after the EUA termination date). In addition, manufacturers should be
aware of any applicable legal requirements for their device, such as adverse event reporting
under 21 CFR Part 803, and are expected to comply with such requirements for the duration in
which they are applicable, which may extend beyond the cessation of distribution.
For IVDs authorized under an EUA for use in high complexity, moderate complexity, and
waived settings that were already distributed before the EUA termination date, at this time, FDA
does not intend to object to the continued use of such tests prior to the product expiration date in
a manner consistent with the EUA that was in effect prior to the EUA termination date.78
Manufacturers may also voluntarily withdraw their devices from the market. For manufacturers
that do not intend to continue distributing their devices and that intend to voluntarily withdraw
their devices from the market, FDA recommends completing withdrawal of the devices from the
market prior to the EUA termination date; otherwise, if withdrawal of the devices from the
market is not completed prior to the EUA termination date, FDA recommends restoring and/or
updating labeling for reusable non-life-supporting/non-life-sustaining devices and for reusable
life-supporting/life-sustaining devices as outlined in the policy above prior to the EUA
termination date. Manufacturers should be aware of any applicable legal requirements for their
device, such as adverse event reporting under 21 CFR Part 803, and continue to comply with
such requirements for the duration in which they are applicable, which may extend beyond the
cessation of distribution or withdrawal. Generally, it is anticipated that, over time, legal
requirements will no longer apply when the manufacturer’s device withdrawal activities are
completed.
FDA encourages manufacturers that do not intend to continue to distribute their devices after the
EUA termination date to communicate with device distributors, healthcare facilities, healthcare
providers, patients, and consumers, as appropriate, regarding their product disposition to assist
all stakeholders with transition planning. In addition, thinking through elements of the
“Transition Implementation Plan” outlined in Section V.B.(1) of this guidance may help
manufacturers and stakeholders with this process.
D. Discontinuing distribution of a device
FDA expects manufacturers to discontinue distribution of a device within the scope of this
guidance:
1) On the EUA termination date, if the manufacturer has not submitted a required
marketing submission79 for its device and had it accepted by FDA before the EUA
termination date; or
2) On the date the manufacturer receives a negative decision on its marketing submission
78 Laboratories using such tests should consider whether CLIA requirements administered by CMS may apply.
79 See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.

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as FDA’s final action, or on the date the manufacturer withdraws its submission or
fails to provide a complete response to an FDA request for additional information80
within the allotted time identified in FDA’s letter.
In addition, manufacturers should be aware of any applicable legal requirements for their device,
such as adverse event reporting under 21 CFR Part 803, and continue to comply with such
requirements for the duration in which they are applicable, which may extend beyond the
cessation of distribution. Generally, to help determine the applicable legal requirements after
cessation of distribution, FDA expects manufacturers of devices and others81 to review terms of
the devices’ respective EUAs, including the conditions of authorization82 that were included in
the EUA letters of authorization for the devices.
FDA encourages manufacturers to communicate with device distributors, healthcare facilities,
healthcare providers, patients, and consumers, as appropriate, regarding their product disposition
to assist all stakeholders with transition planning.
E. Quality System considerations
FDA recognizes that there may be situations that raise unique compliance considerations,
particularly regarding QS requirements. For example, non-traditional device manufacturers that
previously operated under different quality standards or requirements may face challenges that
take more time to address in transitioning to a system that fully complies with 21 CFR Part 820.
FDA intends to take such considerations into account when making case-by-case compliance and
enforcement decisions. Some manufacturers who intend to continue distributing their devices
after the EUA termination date may choose to request an exemption or variance from a device
QS requirement as outlined in 21 CFR 820.1(e) and section 520(f)(2) of the FD&C Act. Any
such exemption or variance should be requested within 90 days of publication of the advance
notice of termination of the EUA declaration pertaining to the device at issue to help ensure FDA
considers your request in time.
F. Laboratory developed tests (LDTs)
For laboratory developed tests (LDTs)83 in general, FDA has generally exercised enforcement
discretion, meaning that FDA generally does not exercise its authority to enforce the regulatory
requirements for these devices, although it maintains that authority. FDA has not applied this
general enforcement discretion approach to, among other LDTs, those used for declared
emergencies under section 564 of the FD&C Act. As such, following termination of the EUA
80 For more information on FDA requests for additional information (i.e., deficiency letters) and how to respond, see
the guidance “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions,”
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-
responding-deficiencies-accordance-least-burdensome-provisions.
81 Certain EUAs include conditions of authorization for parties other than the manufacturer, such as healthcare
facilities or distributors.
82 See section 564(e) of the FD&C Act.
83 An LDT is a type of IVD that is designed, manufactured, and used within a single site laboratory certified under
CLIA that meets the requirements to perform tests of high complexity.

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declaration for COVID-19 IVDs,84 FDA intends to have the same enforcement approach for
COVID-19 LDTs as it does for other LDTs.
VI. Examples
The following hypotheticals are intended to illustrate the transition policy outlined above. To
exemplify the timeline of the Transition Implementation Plan outlined in this section (Section
VI. of this guidance), for purposes of the examples, FDA set the hypothetical advance notice of
termination date for the EUA declaration pertaining to the device at issue as July 1 in Year 1, and
the EUA termination date as January 1 in Year 2. This date is not intended to propose an actual
advance notice of termination or EUA termination date; it is hypothetical and for illustrative
purposes only. Note that these generalized examples do not account for every possible detail,
risk, or consideration a manufacturer should evaluate or that may be relevant to FDA decisions
regarding a particular device.
Example 1
A single-use surgical mask that is intended for use in healthcare settings by healthcare personnel
as personal protective equipment to provide a physical barrier to fluids and particulate materials
was authorized for emergency use under an umbrella EUA for surgical masks.85 The
manufacturer does not intend to continue distributing the surgical mask after the EUA is no
longer in effect.
On July 1, the advance notice of termination of the relevant EUA declaration is published. After
July 1, the manufacturer continues to distribute the surgical masks and continues to comply with
all conditions of authorization.
On the EUA termination date (January 1), the relevant EUA declaration is terminated and the
umbrella EUA is no longer in effect. On January 1, the manufacturer ceases distribution of the
surgical mask. Before January 1, the manufacturer had recently sold surgical masks directly to
retailers and device distributors. Some of the surgical masks are in transit to these customers, and
others are being held in device distributors’ warehouses in the U.S.
The policies included in this guidance relate to the following actions by the device manufacturer
and others:
· The surgical masks in transit or in device distributors’ warehouses remain distributed
(they were already distributed by the EUA termination date), and they are used by the end
user prior to their expiration date.
· If on January 1, some of the surgical masks are in the manufacturer’s possession, the
surgical masks in the manufacturer’s possession are not subsequently distributed (they
were not already distributed by the EUA termination date).
84 HHS declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of the SARS-CoV-2 virus that causes COVID-19 (issued February 4, 2020 (85 FR 7316)
and amended March 15, 2023 (88 FR 16644)).
85 Available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/personal-protective-equipment-euas#surgicalmasks.

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· The manufacturer does not update the labeling of the already distributed surgical masks
(they are single-use, non-life-supporting/non-life-sustaining devices).
· User exhaustion of already distributed surgical masks is described in Section V.C. of this
guidance.
· Even after the cessation of distribution, the manufacturer continues to submit any adverse
event reports of which it becomes aware to FDA consistent with 21 CFR Part 803.
Example 2
A continuous ventilator was authorized under the umbrella EUA for ventilators and ventilator
accessories86 to support patients who develop respiratory distress due to COVID-19.
On July 1, the advance notice of termination of the relevant EUA declaration is published.
Before August 1, to help FDA plan for transition-related premarket review activities, the
manufacturer submits an “EUA report” to the CDRH Document Control Center with “Attention:
Notification of Intent” on the cover letter of the submission to inform FDA that it does not intend
to pursue marketing authorization. This EUA report includes the information outlined in Section
V.A. of this guidance, which includes the manufacturer’s plans to have already distributed
ventilators remain distributed.
On the EUA termination date (January 1), the relevant EUA declaration is terminated and the
umbrella EUA is no longer in effect. On January 1, the manufacturer ceases distribution of the
ventilator. FDA does not intend to object if the manufacturer implements a plan (that was
included in the Notification of Intent) for the already distributed ventilators to remain distributed
(e.g., ventilators in device distributors’ warehouses), including ventilators in the possession of
end users (e.g., ventilators in healthcare facilities). As part of the plan, the manufacturer interacts
with affected stakeholders, such as healthcare facilities, to determine the stakeholders’ interest in
keeping distributed ventilators. The ventilator manufacturer updates the electronic labeling as
outlined in Section V.C. of this guidance, and emails a copy of the electronic labeling to affected
stakeholders that have expressed an interest in keeping the ventilators.
The policies included in this guidance relate to the following actions by the device manufacturer
and others:
· The already distributed ventilators are not used.
· Should healthcare facilities wish to retain the ventilator that lacks FDA clearance,
approval, or authorization for use in the future, the future use of the device would be
subject to the regulatory requirements of any future authorization, including marketing
authorization or EUA.
· For governmental stockpilers that wish to retain a device that lacks requisite FDA
clearance, approval, or authorization for use in the future, FDA recommends engaging
with the Agency to discuss the public health need for future deployment and/or use of the
device in specific circumstances (e.g., regional natural disaster, localized disease
outbreaks).
86 Available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/ventilators-and-ventilator-accessories-euas.

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· Even after the cessation of distribution, the manufacturer continues to submit any adverse
event reports of which it becomes aware to FDA consistent with 21 CFR Part 803.
Example 3
A non-traditional device manufacturer worked with a traditional device manufacturer (original
equipment manufacturer (OEM)) to produce, as a contract manufacturer, ventilators that were
designed by the traditional device manufacturer. Such devices were authorized under the
umbrella EUA for ventilators and ventilator accessories87 and distributed by the OEM during the
COVID-19 pandemic.
On July 1, the advance notice of termination of the relevant EUA declaration is published.
Before August 1, to help FDA plan for transition-related premarket review activities, the OEM
submits an “EUA report” to the CDRH Document Control Center with “Attention: Notification
of Intent” on the cover letter of the submission to inform FDA that it intends to pursue marketing
authorization. This EUA report includes the information outlined in Section V.A. of this
guidance.
On October 1, the OEM submits a marketing submission to FDA. In its marketing submission,
the OEM includes a “Transition Implementation Plan” for already distributed ventilators in the
case of a positive decision as well as in the case of a negative decision on the marketing
submission. On October 10, the marketing submission is determined to be administratively
incomplete because it is missing a test report for a biocompatibility endpoint; the marketing
submission is not accepted for review (an “RTA1 decision”). The OEM resolves the acceptance
review deficiency by including the missing test report for the biocompatibility endpoint and
resubmits the marketing submission on November 1. On November 8, the marketing submission
is accepted for substantive review.
On the EUA termination date (January 1), the relevant EUA declaration is terminated and the
umbrella EUA is no longer in effect. The OEM has submitted a marketing submission and it was
accepted by FDA. Under these circumstances, FDA does not intend to object to the continued
distribution of the ventilators before FDA takes a final action on the marketing submission (see
Section V.B.(2) of this guidance). Additionally, the OEM has kept the device labeling as
described in the EUA-authorized device labeling. Under these circumstances, FDA does not
intend to object to the device labeling not complying with applicable labeling requirements (see
21 CFR Part 801) where the device continues to be labeled as previously authorized under the
EUA while the marketing submission is under FDA review (see Section V.B.(2) of this
guidance).
In this scenario, in the course of FDA’s substantive review, FDA identifies a potential control
software issue that could result in patient harm. FDA issues a request for additional information
and informs the OEM that the marketing submission is being placed on hold pending receipt of a
response to the deficiency. The OEM updates its software, performs the appropriate testing, and
provides additional information and a response to the deficiency.
87 Available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/ventilators-and-ventilator-accessories-euas.

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On July 10, the OEM receives a positive decision as part of FDA’s final action on the marketing
submission. FDA and the OEM engage on the manufacturer’s Transition Implementation Plan to
address already distributed devices, which includes the manufacturer updating software for
already distributed ventilators and providing updated electronic labeling to the relevant
stakeholders in accordance with the FDA-cleared version of the ventilator. The OEM continues
to submit any adverse event reports of which it becomes aware to FDA consistent with 21 CFR
Part 803.
Example 4
A molecular diagnostic test kit manufactured by a commercial manufacturer was issued an
individual EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and
lower respiratory specimens in authorized laboratories.88
On July 1, the advance notice of termination of the relevant EUA declaration is published. On
October 1, the manufacturer submits a marketing submission to FDA, which is accepted by the
Agency. In its marketing submission, the manufacturer includes a “Transition Implementation
Plan” for already distributed molecular diagnostic test kits in the case of a positive decision as
well as in the case of a negative decision on the marketing submission.
On the EUA termination date (January 1), the relevant EUA declaration is terminated and the
EUA for the device is no longer in effect. The manufacturer has submitted a marketing
submission and it was accepted by FDA. Under these circumstances, FDA does not intend to
object to the continued distribution of the device before FDA takes a final action on the
marketing submission (see Section V.B.(2) of this guidance). Additionally, the manufacturer has
kept the device labeling as described in the EUA-authorized device labeling. Under these
circumstances, FDA does not intend to object to the device labeling not complying with
applicable labeling requirements (see 21 CFR Part 801) where the device continues to be labeled
as previously authorized under the EUA while the marketing submission is under FDA review
(see Section V.B.(2) of this guidance).
a) Positive Decision
In this scenario, the manufacturer receives a positive decision on February 20, as part of FDA’s
final action on the marketing submission. FDA and the manufacturer engage on the
manufacturer’s Transition Implementation Plan to address already distributed devices. The
manufacturer does not update the device labeling for already distributed devices (these devices
are single-use, non-life-supporting/non-life-sustaining devices); however, the manufacturer
updates the device labeling for devices that are in production and those in its possession in
accordance with the FDA-cleared version of the molecular diagnostic test kit. No outstanding
issues were identified during FDA review that would result in a correction or removal of the
molecular diagnostic test kits that were already distributed. The manufacturer continues to
88 Available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-
molecular.

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submit any adverse event reports of which it becomes aware to FDA consistent with 21 CFR Part
803.
b) Negative Decision
In this scenario, the manufacturer receives a negative decision on March 1, as part of FDA’s final
action on the marketing submission. FDA and the manufacturer engage on the manufacturer’s
Transition Implementation Plan to address already distributed devices. During FDA’s
substantive review, FDA found that specific lots of the molecular diagnostic test kit had a high
number of false positive reports, which may lead to a delay in both the correct diagnosis and
treatment for the actual cause of a person’s illness. The manufacturer issues a voluntary recall for
the affected lots of the molecular diagnostic test kit by informing relevant stakeholders to dispose
of the affected lots.
The policies included in this guidance relate to the following actions by the device manufacturer
and others:
· For unaffected lots of the molecular diagnostic test kit that are not subject to the recall
and are already distributed, the devices remain distributed with device distributors and
retail sellers who have already purchased the devices so that they may be used prior to the
product expiration date.
· The manufacturer has a small number of unaffected lots of the molecular diagnostic test
kit that are not subject to the recall in its possession; the manufacturer does not distribute
these devices.
· The manufacturer does not update the device labeling of already distributed devices
(these devices are single-use, non-life-supporting/non-life-sustaining devices); however,
the manufacturer does communicate publicly about the recall about the affected lots of
the molecular diagnostic test kit.
· Even after the cessation of distribution, the manufacturer continues to submit any adverse
event reports of which it becomes aware to FDA consistent with 21 CFR Part 803.