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

Center for Devices and Radiological Health

November 17, 2021
2

Resources for COVID-19 Test Development and Validation

How to Receive Information and Ask Questions by Email: 

• To receive CDRH IVD topic emails, please 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 please email: CDRH-EUA-Templates@fda.hhs.gov

• For questions about laboratory data harmonization for COVID - 19 testing please email: SHIELDLabCodes@fda.hhs.gov

Where to find CDRH Information: 

• In Vitro Diagnostics EUAs webpage: 

www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizationsmedical-devices/vitro-diagnostics-euas

• Policy for Coronavirus Disease - 2019 Tests During the Public Health Emergency (Revised Nov. 2021) 

www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease2019-tests-during-public-health-emergency-revised

• FAQs on COVID - 19 Testing - Developers: www.fda.gov/medical-devices/emergency-situationsmedical-devices/faqs-testing-sars-cov-2
3

November 15, 2021, Actions

*These slides present high level discussion points. Please refer to the guidance and EUAs for the details and official polic ies . 

• HHS Statement regarding LDTs: 

• Statement by HHS Secretary Xavier Becerra on Withdrawal of HHS Policy on 

Laboratory-Developed Tests

• “Effective today, HHS no longer has a policy on LDTs that is separate from FDA’s 

longstanding approach in this area.”

• FDA Press Release regarding multiple actions: 

• Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure 

Accuracy and Reliability of Tests and Increase Access to At-Home Tests

• “By focusing our review on [tests that will have the biggest impact on the 

nation’s ongoing COVID - 19 testing needs, such as at - home and point - of - care 

diagnostic tests that can be produced in high volumes], and helping to ensure 

that available tests have appropriate oversight, we can better respond to the 

pandemic as the nation’s testing needs continue to evolve.” 
4

COVID-19 Test Policy

• Reissued Guidance: 

• Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency 

(Revised)

• Main Policy Areas: 

• Prioritization of Review of EUA Requests for Tests – Section IV.A 

• State Authorization – Section IV.B 

• Distribution and Offering of Tests During FDA Review – Section IV.C 

• Modifications to EUA - Authorized Diagnostic COVID - 19 Tests – Section IV.D 
5

Guidance: EUA Review Priorities

*Details in Section IV.A of the COVID-19 Test Policy

FDA generally intends to focus its review on EUA requests for the following types of 

tests (please see the guidance for additional details for each of these types of tests): 

• At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that 

can be manufactured in high volumes; 

• Certain high - volume, lab - based molecular diagnostic tests (and home collection kits for use 

with such tests) that expand testing capacity or accessibility such as through pooling of 

specimens to increase throughput, testing specimens collected at home and shipped to the lab, 

screening asymptomatic individuals, or detecting multiple different respiratory viruses at once; 

• Certain lab - based and POC high volume antibody tests that can measure the amount of 

antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies; and 

• Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the 

Biomedical Advanced Research and Development Authority or the National Institutes of Health’s 

Rapid Acceleration of Diagnostics (RADx). 
6

Guidance: Background & Scope

• Enforcement policies in the Guidance do not address MDR (21 CFR Part 803); 

developers are expected to comply with applicable MDR requirements for tests 

offered prior to authorization as described in the guidance 

• Unless and until an EUA is issued that authorizes additional testing environments for 

a specific test, under CLIA, use of that test is limited to laboratories that are certified 

under CLIA, and meet the requirements to perform tests of high - complexity, and at 

the point - of - care (POC) when covered by such a laboratory’s CLIA certificate 

• Policies regarding offering COVID - 19 tests prior to or without an EUA have never 

applied to at - home tests or tests with home specimen collection, or any testing 

outside of a high - complexity CLIA - certified laboratory 

• Notification policies have never applied to multi - analyte respiratory panels 
7

Guidance: Appendix A Flowcharts

*The flowcharts above give a general overview of the policies in Section IV.A of the COVID-19 Test Policy. Readers should refer to 

that section for the policies themselves. The flowcharts do not address policies discussed in other sections of this guidance . 
8

Guidance: State Authorization

*Details in Section IV.B of the COVID-19 Test Policy

• Previous Policy: Addressed States and territories that authorize laboratories within 

their State or territory to develop their own COVID - 19 tests and perform specimen 

testing, where the notification of SARS - CoV - 2 test validation is not submitted to FDA 

and the laboratory does not submit an EUA request to FDA 

• Updated Policy: FDA no longer intends to apply the policy to any additional States 

or territories going forward 

• For the States and territories listed on the notification list on FDA’s website prior to November 15, 2021, that are 

continuing to authorize laboratories within that State or territory to develop and perform a test for COVID - 19, FDA does 

not intend to object to the use of such tests for specimen testing where the notification of SARS - CoV - 2 test validation is 

not submitted to FDA and the laboratory does not submit an EUA request to FDA, and where instead the State or 

territory takes responsibility. 

• This policy applies only to tests designed, developed, and used within a single, highcomplexity CLIA-certified laboratory.
9

Guidance: 

Distribution and Offering of Tests During FDA Review

*Details in Section IV.C of the COVID-19 Test Policy

• Previous Policies: 

• FDA Guidance: Addressed distribution and offering of certain tests for clinical use prior to or 

without an EUA – “notification policies” 

• HHS August 2020 Announcement: Addressed, among other things, laboratory developed tests 

(LDTs) for SARS - CoV - 2 offered without FDA authorization 

• Updated Policy: FDA generally expects COVID - 19 tests to have been issued an 

Emergency Use Authorization (EUA) or marketing authorization (PMA, de novo, 

510(k)) prior to the tests being distributed or offered 

• HHS withdrew August 2020 policy 

• FDA is ending notification policies going forward 

• EUA request generally expected for tests currently being offered without the submission of an 

EUA request, as described in the guidance 

• FDA generally intends to review the EUA requests 

• If the test is not subsequently authorized, developers expected to cease marketing the test 

within 15 calendar days of being notified 
10

Guidance: Appendix B Flowchart

*The flowchart above gives a general overview of the policies in Section IV.C of the COVID-19 Test Policy. Readers should refer to 

that section for the policies themselves. The flowchart does not address policies discussed in other sections of this guidanc e. 
11

Guidance: 

Modifications to EUA-Authorized Diagnostic COVID-19 Tests

*Details in Section IV.D of the COVID-19 Test Policy

• Policies regarding offering modifications to EUA - authorized tests prior to or without 

an EUA have never applied to at - home tests or tests with home specimen 

collection, or any testing outside of a high - complexity CLIA - certified laboratory 

• Transparency: recommendations regarding test reports and other information 

• Developer should post data about the modified test’s performance characteristics on its website 

• Instructions for use or test protocol and the test reports should reflect the modification, 

disclose that the test has been modified and modified test has not been reviewed by FDA 

• If FDA identifies a significant problem or concern with a modified test, based either 

on the provided information or external reports, that cannot be addressed in a 

timely manner, FDA generally would expect the developer to cease distribution, 

marketing and offering the modified test and address such problem, which could 

include conducting a recall of the modified test and/or notification concerning 

corrected test reports indicating prior test results may not be accurate.
12

Guidance: 

Modifications Made Before and After Guidance Update

*Details in Section IV.D of the COVID-19 Test Policy

• Modifications made before November 15, 2021 

• For modifications made and implemented as discussed in the policies in the previous version of 

the guidance, FDA does not intend to object to the following: 

• For modifications by a commercial manufacturer to its own EUA - authorized test: continued 

implementation of the modification while FDA reviews the EUA request 

• For modifications made and implemented by high - complexity CLIA - certified laboratories: continued 

offering of the modified test 

• Modifications made after November 15, 2021 

• For modifications that do not change the indication for use set forth in the EUA and do not 

change the analyte specific reagents, FDA does not intend to object to the following: 

• For modifications by a commercial manufacturer to its own EUA - authorized test: implementation of 

the modification while FDA reviews the EUA request 

• For modifications made and implemented by high - complexity CLIA - certified laboratories: 

implementation of the modification without notification to FDA or a new or amended EUA, where the 

laboratory has validated the modification, confirmed equivalent performance as the authorized test, 

and use of the test is limited to the high - complexity CLIA - certified laboratory in which the 

modification was made 
13

New Umbrella EUA – Serial Testing

*Details in the EUA Letter of Authorization - Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

• Issued Umbrella EUA: for serial testing with certain molecular diagnostic tests 

developed by laboratories: 

• Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing

• Used for testing at regular intervals as part of serial testing programs, such as those 

established at places like schools, workplaces or community groups 

• Efficiently authorizes certain tests that meet specified criteria 

• For use with individual or pooled anterior nasal specimens for testing individuals, including 

individuals without symptoms or other epidemiological reasons to suspect COVID - 19, when 

tested at least once per week 

• Options to include testing with home collected specimens 

• Appendices include validation required to be authorized for each optional indication 

• Limited to use in the single laboratory that developed the authorized test and that is certified 

under CLIA and meets requirements to perform high complexity tests 
14

Additional Actions

*Details in the documents and websites linked below. 

• Website Updates: 

• FAQs on Testing for SARS-CoV-2 

• Coronavirus (COVID-19) and Medical Devices

• EUA - related pages 

• Reissued March 2020 EUA for Certain Molecular Diagnostic Tests: 

• EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories 

Certified Under CLIA To Perform High Complexity Tests

• Only tests that are listed in Appendix A are authorized for use as described in the EUA 

• No additional tests will be authorized by this EUA 

• Updated Conditions of Authorization and Fact Sheets to reflect the most up - to - date 

information 

• Reissued July 2020 VTM Guidance: 

• Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) 

Public Health Emergency

• Revised to update references to the Policy for Coronavirus Disease - 2019 Tests During the 

Public Health Emergency
15

Let’s Take Your Live Questions

• To Ask a Question: 

1. Please “Raise Your Hand” 

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

3. Unmute yourself when called to ask your question 

• When Asking a Question: 

4. Announce your first, last, and business name

5. Ask your question, 1 question only 

6. Please, no questions about specific submissions 

• After Question is Answered: 

7. Please mute yourself again 

8. If you have more questions - raise your hand again
16

Thanks for Joining Today!

• Presentation and Transcript will be available at: 

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

• Heading “Specialty Technical Topics”

• Sub - Heading “Coronavirus (COVID - 19) Test Development and Validation 

Virtual Town Hall Series”

• If you have additional questions about today’s presentation/topics?

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

• Give Us Your Feedback – Fill Out this Short Survey:

www.fda.gov/CDRHWebinar

Next Town Hall: December 1, 2021