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Today’s Topic:

Final Guidances on COVID-19 Transition Plans for:

(1) Medical Devices That Fall within Enforcement Policies Issued 

During the COVID-19 Public Health Emergency and 

(2) Medical Devices Issued Emergency Use Authorizations Related to COVID-19

April 18, 2023
COVID-19 Transition Plans for Devices

Kathryn Drzewiecki, PhD

Policy Advisor

Office of Policy

Melissa View, JD

Regulatory Policy Analyst

Office of Policy

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Kathryn Drzewiecki, PhD

Policy Advisor

Office of Policy

3
Final Guidances

• Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued 

During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency – Referred to as “Enforcement Policies Transition Guidance”

– www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medicaldevices-fall-within-enforcement-policies-issued-during-coronavirus-disease

• Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) 

Related to Coronavirus Disease 2019 (COVID-19) – Referred to as “EUA Transition Guidance”

– www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medicaldevices-issued-emergency-use-authorizations-euas-related-coronavirus-disease

• Collectively referred to as “COVID-19 Transition Guidances” in this presentation

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Learning 

Objectives

 Describe background of COVID-19 

public health emergency declarations 

that relate to these final guidances

 Provide a summary of comments 

received and changes made to draft 

guidances

 Review scope of final guidances, 

including timeframes for FDA and 

stakeholder actions

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Background

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Background •Declaration of PHE under section 319 of the PHS Act by HHS on January 31, 2020; 

most recently renewed February 11, 2023; PHE expires on May 11, 2023

•Determination and declarations under section 564 of the FD&C Act remain in effect

• Three EUA declarations in 2020: certain in vitro diagnostics; respiratory protective 

devices; and devices, including alternative products used as devices

PHE and EUA 

declarations

•Over 950 EUAs have been issued for COVID-19-related medical devices

• An EUA remains in effect for the duration of the relevant EUA declaration, unless 

revoked by FDA

EUAs

• FDA issued 28 guidance documents describing enforcement policies to support the 

COVID-19 response

•Guidances within the scope of the Enforcement Policies Transition Guidance (“List 1”, 

15/28) originally stated that were intended to remain in effect only for the duration 

of the COVID-19 PHE; now, the guidances in List 1 state that they are intended to 

continue in effect for 180 days after the section 319 PHE declaration expires

Enforcement 

policies

Public Health Emergency (PHE)

Public Health Service Act (PHS Act)

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Emergency Use Authorization (EUA)

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Background

PHE under 

section 319 

PHS Act

Determination 

that PHE exists

January 31, 2020

Letter to Governors: 

HHS will provide 60 

days notice prior to 

PHE expiring

January 22, 2021

Latest renewal of 

determination that 

PHE exists

February 11, 2023

PHE 

declaration 

expires

May 11, 2023

Circumstances 

exist justifying 

EUA under 

section 564 

FD&C Act

Declaration for 

IVDs

February 4, 2020

Declaration for 

personal 

respiratory 

protective devices

March 2, 2020

Declaration for 

devices, including 

alternative products 

used as devices

March 24, 2020

Amended EUA 

declaration

March 15, 2023

• Determination under section 319 of the PHS Act does not enable FDA to issue EUAs

• EUA declaration under section 564 of the FD&C Act is distinct from and not 

dependent on PHE declaration under section 319 of the PHS Act

• An EUA may remain in effect beyond duration of the declared PHE

• An EUA remains in effect for the duration of the relevant EUA declaration, unless 

FDA revokes the EUA, applying the statutory criteria for revocation (section 564 of 

the FD&C Act)

EUA termination: 

HHS intends to publish the 

advance notice of termination of 

each EUA declaration pertaining 

to devices in the Federal Register 

180 days before the day on 

which the EUA declaration is 

terminated

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Background

Questions addressed by the COVID-19 

Transition Guidances:

• Why is FDA issuing these guidances now?

• What actions should I take if I do or don’t plan to distribute my 

device after the transition period and the relevant 

enforcement policy is no longer in effect or the relevant EUA 

declaration terminates?

• What important milestones should I know about during the 

transition process?

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Background

Given the magnitude of the COVID-19 pandemic, FDA recognizes it will take time for stakeholders to 

adjust from policies adopted and operations implemented during the COVID-19 pandemic to normal 

operations

There were many unique considerations presented by the COVID-19 pandemic, including 

manufacturing of devices by non-traditional manufacturers and distribution and use of capital or 

reusable equipment

FDA developed the COVID-19 Transition Guidances to provide stakeholders with recommendations 

and an appropriate transition period to ensure an orderly and transparent transition to normal 

operations

The approach described in the COVID-19 Transition Guidances is expected to help ensure that 

devices meet applicable requirements after the transition period and help avoid disruptions in 

device supply

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Summary of Comments Received and 

Changes to COVID-19 Transition Guidances

11
Summary of Comments Received

Comments on both COVID-19 Transition Guidances:

• Requested clarifications regarding “publicly available” 

labeling and devices considered “already distributed”

• Suggested inclusion of reference to the use of real-world 

evidence in marketing submissions

• Feedback regarding unique device identification 

implementation

• Requested that stakeholders are made aware of 

manufacturers’ plans for the transition

Comments on Enforcement Policies Transition Guidance:

• Transition timeline extension

Comments on EUA Transition Guidance:

• Suggested removal of the recommendations for interim labeling

• Requested clarification regarding policies for IVDs, including application of CLIA, dual 

submissions, and LDTs

In vitro diagnostics (IVDs)

Clinical Laboratory Improvement Amendments (CLIA)

Laboratory developed tests (LDTs)

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EUA 

Transition 

Guidance

20 

Enforcement 

Policies 

Transition 

Guidance

42* 

COVID-19 

Transition 

Draft 

Guidances

*35 unique commenters

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Summary of Changes from 

Draft to Final • Revised labeling recommendations:

• Updated labeling can be provided as either a physical copy or an electronic copy 

(stakeholders may request a physical copy of updated labeling for reusable, lifesupporting/life-sustaining devices)

• Removed recommendation for interim labeling (EUA Transition Guidance)

• Provides enforcement policy that while the device marketing submission is under FDA review, 

FDA does not intend to object if devices continue to be labeled as previously authorized 

under the EUA or as described in the relevant List 1 guidance 

• Additional clarity on many topics, including:

• Devices considered to be “already distributed”

• Real-world data, which may have been obtained as a result of device use during the COVID19 pandemic, may be submitted in support of a marketing submission

• IVDs, including CLIA and LDTs

• Recommendations for stakeholder collaboration regarding transition planning

• Additional explanation and examples to clarify these policies 13
COVID-19 Transition Guidances:

Scope and Timeframes

Melissa View, JD

Regulatory Policy Analyst

Office of Policy

14
Transition period in the COVID-19 

Transition Guidances

Introduction

Background

Scope

Guiding Principles

Transition Plan

Examples

COVID-19 

Device 

Transition

Enforcement 

Policies Transition 

Guidance 

(319 PHE 

Declaration)

EUA Transition 

Guidance 

(564 EUA 

Declarations)

End of 319/PHE

Transition

End of 564/EUA

15
Scope

Enforcement Policies 

Transition Guidance 

• Devices that fall within enforcement policies within scope of guidance identified in “List 1” (See Appendix)

• Does not apply to:

Guidance URL

Policy for COVID-19 Tests (Revised) www.fda.gov/regulatory-information/search-fda-guidance-documents/policycoronavirus-disease-2019-tests-revised

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests 

(Revised)

www.fda.gov/regulatory-information/search-fda-guidance-documents/policyevaluating-impact-viral-mutations-covid-19-tests-revised

Enforcement Policy for the Quality Standards of the Mammography 

Quality Standards Act During the COVID-19 PHE

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcementpolicy-quality-standards-mammography-quality-standards-act-during-covid-19-publichealth

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used 

to Support Patient Monitoring During the COVID-19 PHE (Revised)

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcementpolicy-non-invasive-remote-monitoring-devices-used-support-patient-monitoringduring

Enforcement Policy for Clinical Electronic Thermometers During the 

COVID-19 PHE

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcementpolicy-clinical-electronic-thermometers-during-coronavirus-disease-2019-covid-19-

public

Enforcement Policy for Face Masks and Barrier Face Coverings During 

the COVID-19 PHE

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/enforcement-policy-face-masks-and-barrier-face-coverings-duringcoronavirus-disease-covid-19-public 16
Scope

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EUA Transition 

Guidance

• Devices issued an EUA under section 564 of the FD&C Act on the basis of a device EUA 

declaration related to COVID-19

• Does not apply to:

• Devices with EUAs that FDA chooses to revoke because the criteria in section 

564(c) of the FD&C Act are no longer met or because other circumstances make 

such revocation appropriate to protect the public health or safety (section 

564(g)(2)(B)-(C) of the FD&C Act)

• Current good manufacturing practice deviations (section 564A(c) of the FD&C 

Act)
Guiding Principles

Orderly, 

transparent 

transition

Risk-based 

approach

FDA action when 

needed

Patient and 

healthcare 

provider access

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Transition is generally aligned 

across both guidances 

Implementation 

date, based on expiration 

of PHE*

180-Day transition 

period

End of transition period 

& enforcement policies 

no longer in effect

Advance notice of 

termination in Federal 

Register

180-Day transition 

period EUA termination date

Devices with issued EUAs

Devices that fall within enforcement policies

* The implementation date is the date the 

COVID-19 section 319 PHE declaration 

expires, which is May 11, 2023 19
Transition is generally aligned 

across both guidances 

Final FDA action

+ 180 Days: FDA expects manufacturers to comply with legal 

requirements applicable to their devices

+ 90 Days: Notification of intent for certain life-supporting/life-sustaining devices 

Beginning of 180-day transition

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When distribution is not intended 

to continue beyond transition

• May be used by the end user prior to the product expiration date Single-use devices, 

non-LS/LS

• May be used if they are:

• Restored to FDA-cleared/approved version, OR

•Have a physical and/or electronic copy of updated labeling that 

accurately describes the product features and states that device lacks 

FDA clearance, approval, or authorization

Reusable, 

non-LS/LS

• May be used if they are restored to FDA-cleared/approved version, OR

• If not restored, a physical and/or electronic copy of updated labeling 

that accurately describes the product features and that device lacks FDA 

clearance, approval, or authorization should be provided, and such 

devices are not used

Reusable, LS/LS

Life-supporting/life-sustaining (LS/LS)

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For devices that were already distributed before the end of the transition (EUA 

termination date or end of Phase 2)
Actions recommended when 

transition begins

Final FDA action

+ 180 Days: FDA expects manufacturers to 

comply with legal requirements applicable to 

their devices

+ 90 Days: Notification of intent for certain 

LS/LS devices 

Beginning of 180-day transition Transition begins on date of 

advance notice of 

termination / 

implementation date

Manufacturers should 

submit any adverse event 

reports (21 CFR 803)

Manufacturers should be 

preparing marketing 

submissions if they intend 

to continue distribution 

after transition

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Actions recommended within 90 days 

after transition begins

Final FDA action

+ 180 Days: FDA expects manufacturers to 

comply with legal requirements applicable to 

their devices

+ 90 Days: Notification of intent for certain 

LS/LS devices 

Beginning of 180-day transition

For devices that fall within 

applicable enforcement 

policies: Follow 21 CFR 806 

(reports of corrections and 

removals), 21 CFR 820 (Quality 

System requirements), and 21 

CFR 807 Subparts B-D

(registration and listing)

Notification of intent for certain 

life-supporting/life-sustaining 

devices

Code of Federal Regulations (CFR) 23
FDA resource planning through Notification 

of Intent for certain devices 

Device types

•List of procodes in 

guidances

•Ventilator and ventilator 

accessories, anesthesia gas 

machines, other respiratory 

devices

•Guidances identify product 

codes for which FDA is 

requesting this information

How and when to submit

• By 90 days after transition 

period begins

• Send to CDRH Document 

Control Center as eCopies

• Cover letter should 

reference any related FDA 

submission numbers

Information requested

• General information

• EUA and related FDA 

submission numbers

• Model numbers

• Future plans to submit 

marketing submission

• Future plans to 

discontinue distribution, 

restore or relabel, and 

other efforts to address 

or mitigate risk of already 

distributed devices

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Actions recommended within 180 days 

after transition begins

EUA declarations are terminated / 

COVID-19 enforcement policies are 

no longer in effect

Manufacturers must comply with 

all legal requirements

Marketing submissions, 

including Transition 

Implementation Plan, should 

have already been submitted to 

and accepted by FDA

Enforcement policy for FDA 

marketing authorization and 

certain labeling and UDI 

requirements during FDA review 

before final FDA action

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Final FDA action

+ 180 Days: FDA expects manufacturers to 

comply with legal requirements applicable to 

their devices

+ 90 Days: Notification of intent for certain 

LS/LS devices 

Beginning of 180-day transition
Transition Implementation Plan will help guide 

consistent FDA-manufacturer interactions

Transition 

Implementation Plan

Include the Transition 

Implementation Plan in the cover 

letter for your marketing submission

Also, as applicable, include in the 

cover letter that the device:

• Is/was previously authorized 

under an EUA and the EUA 

request number

• Is/was distributed as described in 

a policy in a guidance in List 1

• Submission number(s) for related 

premarket submissions

Estimated number of devices in distribution

• Explanation of the benefit-risk based plan for disposition of already 

distributed devices

• Notification to stakeholders of regulatory status

• Process and timeline for restoring device to FDA-cleared/approved version 

or providing a physical and/or electronic copy of updated labeling that 

accurately describes the product features and that device lacks FDA 

clearance, approval, or authorization

• Maintenance plan

Benefit-risk based plan for already distributed 

devices in event of negative decision

• Explanation of plan for addressing already distributed devices

• Notification to stakeholders of regulatory status

• Process and timeline for providing updated labeling or components for the 

FDA-cleared/approved version of the device

Plans for already distributed devices in event of 

positive decision

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FDA expects compliance with legal requirements 

upon final FDA action

Final FDA action

+ 180 Days: FDA expects manufacturers to 

comply with legal requirements applicable to 

their devices

+ 90 Days: Notification of intent for certain 

LS/LS devices 

Beginning of 180-day transition

FDA expects distribution to cease 

when:

• Marketing submission not 

accepted by +180 days

•Negative decision on marketing 

submission

• Marketing submission 

withdrawn or fails to provide 

complete response to request 

for additional information

FDA may take regulatory action as 

appropriate to protect public health

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Kathryn Drzewiecki, PhD

Policy Advisor

Office of Policy

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Scenarios not addressed in guidances:

Please reach out to FDA to discuss

29

• Recommendations, actions, and timeframes described in the 

COVID-19 Transition Guidances generally apply

• Manufacturers may wish to initiate discussions with FDA 

through the Q-Submission Program

• Manufacturers are expected to work toward submission of a 

marketing application on specific timeline

 Note that FDA intends to help facilitate this
Example: Telethermographic System

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A new telethermographic system that falls within the Enforcement Policy for Telethermographic Systems

Phase 1 (Begins 

May 11)

Phase 2 (Begins 

August 9)

Phase 3 (Begins 

November 7)

COVID-19 enforcement 

policy is no longer in effect 

after the 180-day transition 

period ends

All manufacturers continue to comply with the requirements that were not addressed in the enforcement policy, 

regardless of whether they intend to distribute their devices beyond the transition period and the enforcement policies 

are no longer in effect

Manufacturer who intends to distribute beyond transition period:

• Registers and lists (21 CFR Part 807 Subparts B-D)

• By the end of Phase 2, submits a marketing submission, including a Transition Implementation Plan, which is 

accepted by FDA

Manufacturer who does not intend to distribute beyond transition period:

• Ceases distribution during Phase 2

• Continues to report adverse events consistent with 21 CFR Part 803

Manufacturer who intends to distribute beyond transition period:

• Continues to distribute until FDA takes a final action

• Complies with all other legal requirements applicable to the device (such as registration and listing, quality system, 

and reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806)

• In a scenario where the manufacturer receives an NSE decision after FDA’s review:

• Manufacturer ceases distribution

• FDA and manufacturer engage on the Transition Implementation Plan to address already distributed devices

Manufacturer who does not intend to distribute beyond transition period:

• Previously distributed devices remain distributed

• Provides an electronic copy of updated labeling (noting product features and regulatory status)

• Continues to report adverse events consistent with 21 CFR Part 803
Example: Continuous Ventilator

A continuous ventilator was authorized under the umbrella EUA for ventilators

July 1*

Advance notice of termination of the relevant EUA 

declaration is published in the Federal Register 

All manufacturers continue to comply with the requirements in the EUA conditions of 

authorization

August 1*

Manufacturer who intends to distribute beyond EUA termination date:

• Submits a Notification of Intent to inform FDA that it intends to pursue marketing authorization

• By the EUA termination date, submits a marketing submission, including a Transition Implementation Plan, which is 

accepted by FDA

Manufacturer who does not intend to distribute beyond EUA termination date:

• Submits a Notification of Intent, including manufacturer’s plans for already distributed devices, to inform FDA that it 

does not intend to pursue marketing authorization

All manufacturers continue to comply with the requirements in the EUA conditions of authorization

January 1*

Relevant EUA declaration is 

terminated, and the 

umbrella EUA is no longer 

in effect

Manufacturer who intends to distribute beyond EUA termination date: 

• Continues to distribute until FDA takes a final action

• Complies with all other legal requirements applicable to the device (such as registration and listing, quality system, 

and reports of corrections and removals requirements under 21 CFR Parts 807, 820, and 806). 

• In a scenario where the manufacturer receives a positive decision after FDA’s review:

• FDA and manufacturer engage on the Transition Implementation Plan to address already distributed devices

Manufacturer who does not intend to distribute beyond EUA termination date: 

• Ceases distribution and leaves already distributed devices with stakeholders that have expressed interest in keeping 

the devices; however, already distributed devices are not used

*Dates are hypothetical • Provides an electronic copy of updated labeling (noting product features and regulatory status) 31
Appendix

32
Guidances within List 1 of the Enforcement Policies 

Transition Guidance • Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 PHE; www.fda.gov/regulatory-information/search-fdaguidance-documents/enforcement-policy-remote-digital-pathology-devices-during-coronavirus-disease-2019-covid-19-public

• Enforcement Policy for Imaging Systems During the COVID-19 PHE; www.fda.gov/regulatory-information/search-fda-guidancedocuments/enforcement-policy-imaging-systems-during-coronavirus-disease-2019-covid-19-public-health-emergency

• Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the COVID-19 PHE; 

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-fetal-and-maternal-monitoringdevices-used-support-patient

• Enforcement Policy for Telethermographic Systems During the COVID-19 PHE; www.fda.gov/regulatory-information/search-fda-guidancedocuments/enforcement-policy-telethermographic-systems-during-coronavirus-disease-2019-covid-19-public-health

• Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 PHE; www.fda.gov/regulatoryinformation/search-fda-guidance-documents/enforcement-policy-digital-health-devices-treating-psychiatric-disorders-during-coronavirusdisease

• Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the COVID-19 PHE; 

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-extracorporeal-membrane-oxygenation-andcardiopulmonary-bypass-devices-during

• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the COVID-19 PHE; www.fda.gov/regulatoryinformation/search-fda-guidance-documents/enforcement-policy-remote-ophthalmic-assessment-and-monitoring-devices-duringcoronavirus-disease

• Enforcement Policy for Infusion Pumps and Accessories During the COVID-19 PHE; www.fda.gov/regulatory-information/search-fdaguidance-documents/enforcement-policy-infusion-pumps-and-accessories-during-coronavirus-disease-2019-covid-19-public

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Guidances within List 1 of the Enforcement Policies 

Transition Guidance (continued) • Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the COVID-19 PHE; www.fda.gov/regulatoryinformation/search-fda-guidance-documents/enforcement-policy-face-shields-surgical-masks-and-respirators-during-coronavirus-diseasecovid-19

• Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19 PHE; www.fda.gov/regulatory-information/search-fdaguidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health

• Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the COVID-19 PHE; www.fda.gov/regulatoryinformation/search-fda-guidance-documents/enforcement-policy-sterilizers-disinfectant-devices-and-air-purifiers-during-coronavirusdisease

• Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the COVID-19 PHE; www.fda.gov/regulatoryinformation/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-duringcoronavirus

• Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the COVID-19 PHE; 

www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-modifications-fda-cleared-molecular-influenzaand-rsv-tests-during-coronavirus

• Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the COVID-19 PHE (Revised); 

www.fda.gov/regulatory-information/search-fda-guidance-documents/coagulation-systems-measurement-viscoelastic-propertiesenforcement-policy-during-coronavirus

• Enforcement Policy for Viral Transport Media During the COVID-19 PHE (Revised); www.fda.gov/regulatory-information/search-fdaguidance-documents/enforcement-policy-viral-transport-media-during-coronavirus-disease-2019-covid-19-public-health

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Summary

• FDA finalized the COVID-19 Transition Guidances to provide recommendations 

for a return to normal operations for devices that fall within certain 

enforcement policies issued during the COVID-19 PHE or devices issued EUAs – FDA considered public comments received in finalizing the two guidances

• The COVID-19 Transition Guidances identify actions and milestones to support 

FDA and stakeholders through a transparent and orderly transition

– Phase 1 begins on May 11, 2023

• For manufacturers intending to continue to distribute their devices after the 

relevant enforcement policy is no longer in effect, or termination of the 

relevant EUA declaration, FDA recommends preparing your marketing 

submission as soon as possible

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