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 CDRHGuidance@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 FDA12

(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

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,2device 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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2

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.5In 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/regulatoryinformation/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policiesissued-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/proclamationdeclaring-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 (COVID19) 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 product9or 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-transitionroadmap.html.

8 A list of all device EUAs related to COVID-19 is available at https://www.fda.gov/emergency-preparedness-andresponse/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 COVID19 (85 FR 7316), available at https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-ofpublic-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/emergencyuse-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-useauthorization-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-medicalproducts-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.
Contains Nonbinding Recommendations

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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-transitionroadmap.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 QSubmission 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-guidancedocuments/requests-feedback-and-meetings-medical-device-submissions-q-submission-program.
Contains Nonbinding Recommendations

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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 COVID19.

· 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 FDAcleared 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/regulatoryinformation/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methodsand-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.”
Contains Nonbinding Recommendations

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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-andmeetings-medical-device-submissions-q-submission-program.
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A. “Notifications of Intent” for Certain Reusable LifeSupporting 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

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-lifesupporting

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-devicesubmissions.

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-guidancedocuments/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-andfiling-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/acceptancereview-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-supportregulatory-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. 
Contains Nonbinding Recommendations

11

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 lifesupporting/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.
Contains Nonbinding Recommendations

12

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-fdaguidance-documents/fda-and-industry-actions-premarket-notification-510k-submissions-effect-fda-review-clockand-goals; De Novo Actions/Clock guidance, available at https://www.fda.gov/regulatory-information/search-fdaguidance-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-guidancedocuments/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).
Contains Nonbinding Recommendations

13

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/factorsconsider-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

14

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

15

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-dual510k-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.
Contains Nonbinding Recommendations

16

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

17

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.
Contains Nonbinding Recommendations

18

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-andresponding-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.
Contains Nonbinding Recommendations

19

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-useauthorizations-medical-devices/personal-protective-equipment-euas#surgicalmasks.
Contains Nonbinding Recommendations

20

· 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-useauthorizations-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-useauthorizations-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-useauthorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individualmolecular.
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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.