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Policy for Diagnostic Tests for Coronavirus Disease-2019 during the 

Public Health Emergency: Immediately in Effect Guidance

Elizabeth Hillebrenner 

Timothy Stenzel, MD, PhD

Center for Devices and Radiological Health

March 25, 2020
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• Guidance issued February 29, 2020 describes a policy regarding certain 

laboratories immediately using tests they developed and validated while pursuing 

an emergency use authorization (EUA) in order to achieve more rapid testing 

capacity in the U.S.

• Guidance updated March 16, 2020 describes additional policies:

– regarding States taking responsibility for tests developed by certain laboratories 

in their State – regarding manufacturers immediately distributing tests they validated while 

pursuing an EUA – regarding certain serology tests

• To address the COVID-19 public health emergency, the FDA has determined that 

prior public participation for this guidance is not feasible or appropriate and issued 

this guidance without prior public comment.

• This guidance document is immediately in effect, but it remains subject to 

comment in accordance with the FDA's good guidance practices. 

Background
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The guidance includes recommendations regarding: 

• Validating newly developed SARS-CoV-2 tests prior to clinical use

• Notifying FDA when clinical use of a validated test begins 

• Confirming the first 5 positive and negative samples with an EUA authorized test

• Indicating in test reports that the test has been validated but independent review by 

FDA is not yet complete

• Submitting an EUA within 15 business days of initiating testing

• Steps to take if any specimens fail confirmatory testing or if FDA is unable to authorize 

the EUA

A. Policy for CLIA High Complexity Labs Using Their 

Validated Tests Prior to EUA Submission
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The guidance includes recommendations for States or territories regarding:

• Optionally choosing to authorize laboratories within that State or territory to develop and 

perform a test for COVID-19 under authority of its own State law, and under a process 

that it establishes. 

– FDA will not be reviewing the process adopted by the State or territory

– FDA expects that such oversight processes will require laboratories to validate tests 

prior to use.

• Notifying FDA if they choose to use this flexibility to expedite COVID-19 testing in their 

State or territory

The guidance encourages laboratories to notify FDA when starting clinical testing under 

this policy

B. Policy for State Authorization of CLIA High Complexity 

Labs to Perform Testing without Submitting an EUA to 

FDA
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The guidance includes recommendations regarding: 

• Validating newly developed SARS-CoV-2 tests prior to clinical use

• Notifying FDA when distribution for clinical use of a validated test begins 

• Posting the instructions for use, including performance summary, on website

• Indicating in test reports that the test has been validated but independent 

review by FDA is not yet complete

• Submitting an EUA within 15 business days of initiating distribution for clinical 

testing

C. Policy for Commercial Manufacturer Development and 

Distribution of Tests Prior to EUA Submission
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The guidance includes recommendations regarding: 

• Validating newly developed serology tests that detect antibodies to SARS-CoV-2 prior 

to clinical use

• Notifying FDA when clinical use of a validated test begins 

• Indicating in test reports information along the lines of the following: 

– This test has not been reviewed by the FDA 

– Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been 

in contact with the virus. Follow-up testing with a molecular diagnostic should be considered 

to rule out infection in these individuals. 

– Results from antibody testing should not be used as the sole basis to diagnose or exclude 

SARS-CoV-2 infection or to inform infection status. 

– Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus 

strains, such as coronavirus HKU1, NL63, OC43, or 229E.

D. Policy for Commercial Manufacturer Development and 

Distribution and Laboratory Development and Use of 

Serology Tests Without an EUA
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Applicable 

technologies

Validation? Notification to FDA EUA to FDA 

after testing 

initiated?

Location of Testing

Policy A molecular, 

antigen, 

antibody

Yes From high 

complexity lab

Yes High complexity labs 

only

Policy B molecular, 

antigen, 

antibody

Yes From State; 

encouraged from 

labs

Not required High complexity labs 

in certain states only

Policy C molecular, 

antigen, 

antibody

Yes From manufacturer Yes Clinical labs or 

point of care; 

not for home use

Policy D antibody Yes From developer 

(manufacturer or 

high complexity lab)

Not required Clinical labs or 

point of care; 

not for home use

Policy/Recommendation Highlights
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• Clinical Agreement

• Cross Reactivity

• Limit of Detection (for molecular and antigen tests only)

• Inclusivity (for molecular tests only)

• Microbial interference (for antigen tests only)

• Class specificity (for antibody tests only)

Test Validation
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• Notification of clinical use of a validated test should be directed to 

CDRH-EUA-Templates@fda.hhs.gov and should include:

– name of the laboratory or manufacturer

– address

– contact person

– Instructions for use, if distributing a kit

• Notification by a State or territory of their intent to authorize laboratories within that 

State or territory to develop and perform tests for COVID-19 under authority of its own 

State law, and under a process that it establishes should be directed to 

CDRH-EUA-Templates@fda.hhs.gov

• EUA should be submitted to OIR-Operations@fda.hhs.gov and should include:

– Form 3514 available at: 

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080872.pdf

– Completed EUA template available at: https://www.fda.gov/media/135658/download

Submissions to FDA
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# of notifications/

authorizations 

Listings of notifications/ authorizations 

on FDA Website

Policy A 98 https://www.fda.gov/medical-devices/emergency-situationsmedical-devices/faqs-diagnostic-testing-sars-cov-2#labtestpolicy

Policy B 4 https://www.fda.gov/medical-devices/emergency-situationsmedical-devices/faqs-diagnostic-testing-sars-cov-2#whatstate

Policy C 4 https://www.fda.gov/medical-devices/emergency-situationsmedical-devices/faqs-diagnostic-testing-sars-cov2#whatcommanufacturer

Policy D 12 https://www.fda.gov/medical-devices/emergency-situationsmedical-devices/faqs-diagnostic-testing-sars-cov-2#whatserologytest

EUAs 16 https://www.fda.gov/medical-devices/emergency-situationsmedical-devices/emergency-use-authorizations#covid19ivd

Notifications & Authorizations as of 3/24/2020
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• As noted in the guidance, FDA does not intend to object to the use of a test, without a new or 

amended EUA, where the test is validated using a bridging study to an EUA-authorized test. 

• As noted in the guidance, FDA would like to see your validation data informally through an email 

to CDRH-EUATemplates@FDA.HHS.GOV. If FDA’s review of validation data indicates that it 

could be applicable to modifications of other tests with an authorized EUA, and the laboratory 

agrees to FDA sharing that information on our website for use by other laboratories, FDA intends 

to update our FAQs so other laboratories can refer to the validation for their testing, without 

conducting their own bridging study for the same modification. 

• FAQ includes potential alternatives for:

– Swabs

– Transport media

– RNA extraction

– PCR instruments 

– Validation and control materials

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostictesting-sars-cov-2#whatif

Laboratory Modifications to Authorized Tests
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• Modifications to a manufacturer’s EUA-authorized test are submitted as an 

amendment to the EUA. 

• Where validation data supporting the modification has been submitted in the 

amendment, FDA does not intend to object to implementation of the 

modification while FDA conducts its review.

Manufacturer Modifications to Distributed Kits
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• FAQ: https://www.fda.gov/medical-devices/emergency-situations-medicaldevices/faqs-diagnostic-testing-sars-cov-2

• COVID-19 Diagnostic Test Guidance Document: 

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/policy-diagnostics-testing-laboratories-certified-perform-highcomplexity-testing-under-clia-prior

• General EUA Guidance Document: 

https://www.fda.gov/media/97321/download

• FDA’s Novel Coronavirus (COVID – 19) webpage: 

https://www.fda.gov/emergency-preparedness-and-response/mcmissues/novel-coronavirus-covid-19

Resources
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Questions?

For questions on the guidance and accelerated EUA template, or if you wish to 

consider use an alternative specimen type, contact the Division of Microbiology 

devices at (301) 348-1778 or: CDRH-EUA-Templates@fda.hhs.gov.

Slide Presentation, Transcript and Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; Subheading: In Vitro Diagnostics