Timothy Stenzel, M.D., Ph.D., Toby Lowe, Kristian Roth, Ph.D., 

Ryan Lubert, J.D., and Kathryn Drzewiecki, Ph.D.

Center for Devices and Radiological Health

CDRH Virtual Town Hall Series

Test Development and Validation During 

Public Health Emergencies 

(#103 COVID-19)

April 26, 2023
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www.fda.gov/Training/CDRHLearn

CDRH Learn
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COVID-19 Transition Guidance Documents:

IVD-specific Topics
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• Overview of public health emergencies (PHEs) 

and related authorities

• Overview of COVID-19 Transition Guidances

• IVD-specific transition policies and 

recommendations 

COVID-19 IVD Transition – Agenda

*These slides present high level discussion points. Please refer to the statute, regulations, and guidance documents for details and official policies.
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Public Health Emergency Determinations

• Public Health Emergency Determination under Public Health Service Act 

(PHS Act):

• Under section 319 of the PHS Act, the Department of Health and Human Services (HHS) Secretary can 

issue a determination that a “public health emergency” (PHE) exists (the “319 PHE declaration”) 

• The 319 PHE declaration is in effect for 90 days or until the Secretary declares the emergency no 

longer exists; it may be extended by the Secretary in 90-day increments

• The 319 PHE declaration is set to expire on May 11, 2023

• A 319 PHE declaration does not enable FDA to issue EUAs

• Public Health Emergency Determination under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act):

• Under section 564 of the FD&C Act, the HHS Secretary can determine 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 United States citizens living abroad 

(the “564 determination”)

• A 564 determination is not time limited and continues until the HHS Secretary terminates it
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EUA Issuance, Revision, and Revocation

• Criteria for Issuance:

• Serious or life-threatening disease or condition caused by agent

• Product “may be effective” to diagnose, prevent, or treat the condition (lower level of evidence 

than “effectiveness” standard)

• Known and potential benefits outweigh known and potential risks

• No adequate, approved, and available alternative; unavailable includes insufficient supplies of the 

approved alternative

• Emergency Use Authorization (EUA) is temporary

• FDA will periodically review the circumstances and appropriateness of an EUA, including 

circumstances that might warrant revision or revocation of the EUA

• FDA may revoke an EUA for the following circumstances:

• The circumstances for its issuance no longer exist

• The criteria for issuance are no longer met; and/or

• Appropriate to protect the public health or safety

• In general, an EUA will remain in effect for the duration of the EUA declaration 

under which it was issued, unless revoked
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 Transition Plan for Medical Devices That Fall Within Enforcement Policies 

Issued During the Coronavirus Disease 2019 (COVID-19) Public Health 

Emergency

– Referred to as the “Enforcement Policies Transition Guidance”

– https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-planmedical-devices-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 the “EUA Transition Guidance”

– https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-planmedical-devices-issued-emergency-use-authorizations-euas-related-coronavirus-disease

 Collectively referred to as the “COVID-19 Transition Guidances”

COVID-19 Transition Guidances
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 April 18, 2023 – FDA hosted a webinar for stakeholders interested in learning 

more about the COVID-19 Transition Guidances

Help prepare manufacturers and other stakeholders for the orderly and transparent 

transition to normal operations

Describe recommendations regarding submitting a marketing submission and the 

timeline for doing so

Provide examples to illustrate the transition policies and exemplify the 180-day 

transition period timeline

Answer your questions about the guidances on the COVID-19 transition plans

 The presentation, printable slides, and transcript will be available at CDRH Learn under 

“Specialty Technical Topics”, sub-section “COVID-19 Transition Policy”.

https://www.fda.gov/training-and-continuing-education/cdrh-learn

Webinar on COVID-19 Transition Guidances
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 Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued 

During the COVID-19 PHE

– Guidance applies to devices that fall within enforcement policies listed in the 

guidance*

• Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 PHE

• Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During 

the COVID-19 PHE

• Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the 

COVID-19 PHE (Revised)

• Enforcement Policy for Viral Transport Media During the COVID-19 PHE (Revised)

– Certain IVD-related guidances are out of scope 

• Policy for Coronavirus Disease-2019 Tests (Revised) 

• Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised)

Enforcement Policies Transition Guidance

*This is not a complete list of enforcement policies listed in the guidance. See guidance for the complete list. 
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• Prior to transition: 

– Begin preparation of any required marketing submission with a Transition Implementation Plan if 

intending to continue distribution of devices after Phase 2

• May 11, 2023, Phase 1 begins:

– Manufacturers should follow 21 CFR Part 803 (adverse event reporting requirements)

• August 9, 2023, Phase 2 begins: 

– 90 days after the implementation date

– Manufacturers should follow 21 CFR Part 806 (reports of corrections and removals requirements)

– Register and list in accordance with 21 CFR Part 807 Subparts B-D (registration and listing 

requirements) before the start of Phase 2 if the manufacturer intends to continue distribution of 

their devices after Phase 2

– Submit marketing submission to FDA and have it accepted before the start of Phase 3 if the 

manufacturer intends to continue distribution of their devices after Phase 2

• November 7, 2023, Phase 3 begins: 

– 180 Days after implementation date

– Guidances in List 1 are no longer in effect

Enforcement Policies Transition Guidance: 

Implementation Date May 11, 2023
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 Transition Plan for Medical Devices Issued EUAs Related to COVID-19

– Guidance applies to devices with EUAs issued on basis of a COVID-19 EUA 

declaration

– 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

– 180-day advance notice(s) of termination of the EUA declarations pertaining to 

devices – not yet announced

EUA Transition Guidance
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• Prior to advance notice of termination: 

– Comply with the terms of the devices’ respective EUAs

– Plan post-EUA regulatory and disposition strategies

– Begin preparation of any required marketing submission with a Transition Implementation Plan if intending to 

continue distribution of devices after EUA termination

– Consider initiating discussions with the Agency (for example, Pre-Submissions)

• 90-day period after advance notice of termination: 

– Manufacturers that intend to continue distribution of their devices after EUA termination and that have unique 

compliance considerations regarding QS requirements may request an exemption or variance from a device QS 

requirement

• 180-day period between advance notice of termination and the EUA termination date:

– Continue to comply with the terms of the devices’ respective EUAs

– Submit marketing submission to FDA with a Transition Implementation Plan and have it accepted before the EUA 

termination date if intending to continue distribution of devices after EUA termination

• EUA termination date: 

– 180 days after advance notice of termination; EUAs issued under that EUA declaration will be terminated

– Enforcement policy for devices with marketing submission under review by FDA

– Discontinue distribution on EUA termination date if no marketing submission or on date of negative decision on 

marketing submission (or date manufacturer withdraws or fails to provide a complete response)

– Enforcement policy for already distributed devices

EUA Transition Guidance: 

180-Day Advance Notice of Termination
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• CDRH is committed to using fit-for-purpose real-world evidence (RWE) for regulatory decision- making, including using RWE to support the transition from EUA to traditional marketing 

authorization

– National Evaluation System for Health Technologies (NEST) Implementation Cases

• Analysis of point-of-care COVID-19 diagnostic test data, including data from lateral flow 

assays and laboratory tests

• Data derived from real-world sources may be submitted in support of a marketing submission 

or CLIA Waiver by Application

– Various real-world data sources may be available from the use of devices under EUA or 

enforcement policies

– Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical 

Devices

– Engage FDA: 

• Discuss your approach with the review division

• Submit a pre-submission to address specific questions on how real-world data can be 

used to support your premarket submission

EUA Transition Guidance: 

Leveraging Real-World Data
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• Authorization for use in specific settings, specified in an EUA, is effective only while the relevant EUA 

declaration is in effect

• CLIA categorization typically determined by FDA after clearance or approval of a marketing submission:

– Prior to CLIA categorization, an IVD is considered to be high complexity and, under CLIA, use of that test is limited 

to CLIA-certified laboratories that meet the requirements to perform tests of high complexity

– Moderate complexity categorizations – tests will be categorized immediately following FDA’s final action on 

marketing submission

– Waived categorizations – Dual 510(k)/CLIA Waiver by Application pathway (or Dual De Novo/CLIA Waiver)

– Home use – if marketing submission cleared, approved, or authorized for home use, test will be waived by 

regulation, without the need for a CLIA Waiver by Application

• Enforcement policy for devices with marketing submission under review by FDA

– For IVDs authorized under an EUA for use in high complexity, moderate complexity, and waived settings, at this 

time, FDA does not intend to object to the continued distribution and use of such tests consistent with the policy 

described in the guidance and in a manner consistent with the EUA that was in effect prior to the EUA 

termination date

– Laboratories using such tests should consider whether CLIA requirements administered by the Centers for 

Medicare & Medicaid Services (CMS) may apply.

EUA Transition Guidance: 

Additional Considerations – CLIA

See Section V.B.(3) of EUA Transition guidance for full details of policy. 
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For manufacturers of EUA-authorized devices that do NOT intend to continue distributing 

beyond the EUA termination date, FDA does not intend to object to the disposition and 

use of already distributed devices (i.e., FDA does not intend to request market removal) 

where: 

o Single-use, non-life-supporting/non-life-sustaining devices, including IVDs, that were 

distributed before the EUA termination date are used by the end user prior to the product 

expiration date, as applicable

• 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

• Laboratories using such tests should consider whether CLIA requirements administered by the 

CMS may apply

EUA Transition Guidance: 

Devices Not Distributed after EUA Termination Date

See Section V.C. of EUA Transition guidance for full details of policy. 
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• A laboratory developed test (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

• For LDTs 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 declaration for COVID-19 IVDs, FDA 

intends to have the same enforcement approach for COVID-19 LDTs as it does for 

other LDTs

EUA Transition Guidance: 

Laboratory Developed Tests (LDTs)
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Hypothetical example using July 1 of Year 1 as hypothetical advance notice of termination, 

and January 1 of Year 2 as hypothetical EUA termination date:

A molecular diagnostic test kit manufactured by a commercial manufacturer was 

issued an individual EUA for the qualitative detection of nucleic acid from SARSCoV-2 in upper and lower respiratory specimens in authorized laboratories:

• July 1/Year 1 – Advanced notice of termination of the EUA declaration is published

• October 1/Year 1 – Manufacturer submits marketing submission and is accepted by FDA

• January 1/Year 2 – EUA declaration terminated, EUA for device no longer in effect

– FDA does not intend to object continued distribution of the device (with EUA-authorized 

labeling) before FDA takes a final action on the marketing submission

EUA Transition Guidance: 

IVD Example
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• February 20/Year 2 – Positive Decision

– FDA and manufacturer engage on manufacturer’s Transition Implementation Plan to address 

already distributed devices; manufacturer does not update device labeling for already 

distributed devices

– 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

– Manufacturer continues to submit adverse event reports

• March 1/Year 2 – Negative Decision

– FDA and the manufacturer engage on the manufacturer’s Transition Implementation Plan to 

address already distributed devices

– Manufacturer continues to submit adverse event reports, even after cessation of distribution

EUA Transition Guidance: 

IVD Example Resolution
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Previously Emailed Questions
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Resources for COVID-19 Test Development and Validation

How to Receive Updates/Alerts and Ask Questions by Email:

• To receive CDRH IVD update/alert emails, subscribe to the In Vitro Diagnostics Mailing List:

www.fda.gov/about-fda/center-devices-and-radiological-health/subscribe-cdrh-mailing-lists

• For questions about COVID-19 IVD EUAs, email: COVID19DX@fda.hhs.gov

• For questions about laboratory data harmonization for COVID-19 testing, email: 

SHIELD-LabCodes@fda.hhs.gov

Where to Find Information:

• In Vitro Diagnostics EUAs: www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-useauthorizations-medical-devices/vitro-diagnostics-euas

• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency: www.fda.gov/regulatoryinformation/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-healthemergency-revised

• FAQs on Testing for SARS-CoV-2 (Includes: Notifications and Emergency Use Authorizations, At-Home COVID-19 

Diagnostic Tests, Test Development and Review, Test Uses, Testing Supplies, and COVID-19 Related Test Data and 

Reporting): www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: 

www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetingsmedical-device-submissions-q-submission-program

• NIH Independent Test Assessment Program (ITAP): www.nibib.nih.gov/covid-19/radx-tech-program/ITAP
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Let’s Take Your Live Questions

• To Ask a Question:

1. Raise your hand in Zoom

2. Moderator will announce your name and invite you to ask your question

3. Unmute yourself when prompted in Zoom to ask your question

• When Asking a Question:

4. Announce your first, last, and business name

5. Ask one question only

6. No questions about specific submissions 

• After Question is Answered:

7. Mute yourself and lower your hand

8. If you have more questions - raise your hand again
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Thanks for Joining Today!

• Presentation, Slides and Transcript will be available at:

• CDRH Learn: www.fda.gov/Training/CDRHLearn

• Section “Specialty Technical Topics”

• Sub-Section “Public Health Emergencies”

• If you have additional questions about COVID-19:

• Email: CDRH-EUA-Templates@fda.hhs.gov

• Upcoming Webinars:

• www.fda.gov/CDRHWebinar