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 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
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 
1Section 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. 
1 Contains Nonbinding Recommendations
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 
FDAs 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 FDAs 
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, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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 
3Throughout 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.
4The 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. 
5Secretary 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.
6Proclamation 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.
2 Contains Nonbinding Recommendations
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 FDAs 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 
7See 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.
8A 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.
9Under 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.
10Pursuant 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. 
11For more information on FDAs 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.
12See sections 564(f)-(g) of the FD&C Act.
13For additional information on this topic, see FDAs EUA Guidance, at p. 5, footnotes 12 and 15.
3 Contains Nonbinding Recommendations
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
14See sections 564(f)-(g) of the FD&C Act.
15See 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.
16Section 564(b)(2) of the FD&C Act.
17Sections 564(b)(3) and (4) of the FD&C Act.
18FDA 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.
4 Contains Nonbinding Recommendations
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:
19See footnote 10.
20See section 564(b)(2)(A) of the FD&C Act.
21Certain EUAs include conditions of authorization for parties other than the manufacturer, such as healthcare 
facilities or distributors.
22See section 564(e) of the FD&C Act.
23See section 564(h)(1) of the FD&C Act. 
24See footnote 10. 
5 Contains Nonbinding Recommendations
 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. 
FDAs policies and recommendations in this guidance are consistent with the Agencys 
statutory mission to both protect and promote the public health.25
 FDAs 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 
25See section 1003(b) of the FD&C Act.
26Life-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 FDAs product classification database: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm.
27A 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 athttps://www.fda.gov/regulatory-
information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-
and-labeling.
28A 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.
29See sections 564(f)-(g) of the FD&C Act.
3021 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.
6 Contains Nonbinding Recommendations
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 
manufacturers possession that are in transit to or held in a third partys 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 manufacturers 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
31For 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).
32See 21 CFR 820.3(l).
33See 21 CFR 807.3(b) (defining commercial distribution).
34Certain EUAs include conditions of authorization for parties other than the manufacturer, such as healthcare 
facilities or distributors.
35See section 564(e) of the FD&C Act.
36Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.
7 Contains Nonbinding Recommendations
A. Notifications of Intent for Certain Reusable Life
Supporting or LifeSustaining 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
Classification 
Product Code Device Type 
Regulation 
BSZ  Gas-machine, anesthesia  21 CFR 868.5160 
CAW  Generator, oxygen, portable  21 CFR 868.5440 
Humidifier, respiratory gas, (direct 
BTT  21 CFR 868.5450
patient interface)  
High flow/high velocity humidified 
QAV 21 CFR 868.5454 
oxygen delivery device 
CBK  Ventilator, continuous, facility use 
Ventilator, continuous, minimal 
MNT 
ventilatory support, facility use 
NOU  Continuous, ventilator, home use  21 CFR 868.5895 
Ventilator, continuous, non-life-
MNS 
supporting 
ONZ  Mechanical ventilator 
Ventilator, emergency, powered 
BTL  21 CFR 868.5925 
(resuscitator)
No corresponding 
QOO  Ventilator tubing and accessories
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
37The 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.
38Submitting 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 
8 Contains Nonbinding Recommendations
 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 FDAs 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.
41See footnote 40.
42FDA 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.
9 Contains Nonbinding Recommendations
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 manufacturers 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.
44See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
45If 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. 
10 Contains Nonbinding Recommendations
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 devices 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 manufacturers 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 devices 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 FDAs evaluation of the marketing submission, FDA may engage with the 
manufacturer during the Agencys 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 
46While 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 manufacturers Transition Implementation Plan is not prospectively shared with the Agency.
47The 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.
11 Contains Nonbinding Recommendations
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 
4821 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.
49This 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.
50Manufacturers 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.
51For 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.
52Based 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).
12 Contains Nonbinding Recommendations
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 devices 
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 devices 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.
54For more information regarding FDA regulatory requirements for a specific device and FDA policies related to 
those requirements, manufacturers can use the FDA Guidance Search Toolto 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.
55See sections 564(f)-(g) of the FD&C Act.
5621 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.
57See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
13 Contains Nonbinding Recommendations
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. 
FDAs 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 tests 
complexity immediately following FDAs final action on the marketing submission, per FDAs 
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 
58See, e.g., 21 CFR 807.95(a)(1).
59To 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.
6042 U.S.C. 263a.
61See section 564(m)(3) of the FD&C Act. 
62See the FDA website for additional information on CLIA categorizations and FDAs process, available at 
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations.
63Section 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 
14 Contains Nonbinding Recommendations
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 FDAs 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 PublicHealth ServiceAct.
64Available athttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-dual-
510k-and-clia-waiver-application-studies.
65For details on the Q-Submission Program, refer to the guidance Requests for Feedback and Meetings for Medical 
Device Submissions: The Q-Submission Program.
66Laboratories using such tests should consider whether CLIA requirements administered by the Centers for 
Medicare &Medicaid Services (CMS) may apply.
15 Contains Nonbinding Recommendations
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.
67FDA 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.
68FDA uses the term removal consistent with the definition in 21 CFR 806.2(j).
69For 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.
70In 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.
71For 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.
72The 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.
73See footnote 70.
74See footnote 71.
75See footnote 72.
76FDA recognizes that not all use would necessarily be violative (see, e.g., section 564(f)(2) of the FD&C Act).
77Should 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).
16 Contains Nonbinding Recommendations
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 manufacturers 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 
78Laboratories using such tests should consider whether CLIA requirements administered by CMS may apply.
79See, e.g., sections 510(k), 513(f)(2), 515, and 520(m) of the FD&C Act.
17 Contains Nonbinding Recommendations
as FDAs 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 FDAs 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 
80For 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.
81Certain EUAs include conditions of authorization for parties other than the manufacturer, such as healthcare 
facilities or distributors.
82See section 564(e) of the FD&C Act.
83An 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.
18 Contains Nonbinding Recommendations
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 manufacturers possession, the 
surgical masks in the manufacturers possession are not subsequently distributed (they 
were not already distributed by the EUA termination date). 
84HHS 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)).
85Available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/personal-protective-equipment-euas#surgicalmasks.
19 Contains Nonbinding Recommendations
 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 manufacturers 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).
86Available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/ventilators-and-ventilator-accessories-euas.
20 Contains Nonbinding Recommendations
 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 FDAs 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.
87Available athttps://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/ventilators-and-ventilator-accessories-euas.
21 Contains Nonbinding Recommendations
On July 10, the OEM receives a positive decision as part of FDAs final action on the marketing 
submission. FDA and the OEM engage on the manufacturers 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 FDAs 
final action on the marketing submission. FDA and the manufacturer engage on the 
manufacturers 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 diagnostictest kits that were already distributed. The manufacturer continues to 
88Available athttps://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.
22 Contains Nonbinding Recommendations
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 FDAs final 
action on the marketing submission. FDA and the manufacturer engage on the manufacturers 
Transition Implementation Plan to address already distributed devices. During FDAs 
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 persons 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.
23