METADATA
last updated: 2026-03-04 by BA
file_name: 2021-04-20_FDA Website - Pooling and Serial Testing Amendment.md
file_date: 2021-04-20
title: FDA Website - Pooling and Serial Testing Amendment
category: regulatory
subcategory: fda-policy
tags: 
source_file_type: website
xfile_type: NA
gfile_url: NA
xfile_github_download_url: NA
pdf_gdrive_url: NA
pdf_github_url: NA
conversion_input_file_type: docx
conversion: manual cut and paste
license: Public Domain
tokens: 404
words: 298
notes: date converted 2024-03-27
web_url: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#amendment
summary_short: The Pooling and Serial Testing Amendment explains FDA’s April 20, 2021 amendment that allowed certain authorized molecular SARS-CoV-2 tests to use pooled anterior nasal specimens from asymptomatic individuals within serial testing programs after developers submit a complete notification and validation documentation. It specifies CLIA high-complexity laboratory limitations and describes how authorized pooling parameters vary by appendix (pool sizes up to 3, 5, or 10 and media vs. swab pooling). It also clarifies that FDA adding a test to the exhibit/list reflects receipt of required documentation and does not necessarily indicate FDA review of the underlying validation data.


CONTENT

On April 20, 2021, the FDA issued an amendment allowing certain authorized molecular diagnostic SARS-CoV-2 tests to be distributed and used to pool anterior nasal respiratory specimens from asymptomatic individuals as part of a serial testing program after developers submit a complete notification, including meeting required validation data, as set forth in the letter. Use of tests for these indications is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, except that tests authorized for use in specific named or designated high complexity laboratories can only be used in such laboratories.

This means that tests with EUAs that are amended by this authorization may be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a testing program that includes testing at regular intervals, at least once per week. The indications in each appendix (A-H) differ in the number of specimens that can be pooled (up to 3, up to 5, or up to 10) and the type of pooling that can be done (media pooling or swab pooling).

Prior to a test being distributed or used for any new indication, the developer must submit a notification to the FDA with the information required by the amendment, including self-certifying that the applicable validation has been completed. Tests will be added to Exhibit 1 once FDA confirms that the required documentation has been submitted. Please note that being added to Exhibit 1 does not necessarily mean that the FDA has reviewed the underlying validation data submitted or confirmed that the test is appropriately validated.

[Amendment Letter](https://www.fda.gov/media/147737/download?attachment)
[Appendix J - Sample Updated Fact Sheet for Health Care Providers](https://www.fda.gov/media/147735/download?attachment)
[Appendix K - Sample Updated Fact Sheet for Patients](https://www.fda.gov/media/147736/download?attachment)