METADATA
last updated: 2026-03-04 by BA
file_name: 2021-11-15_FDA Website - Umbrella EUA.md
file_date: 2021-11-15
title: FDA Website - Umbrella EUA
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: 507
words: 352
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#umbrella-eua
summary_short: The Umbrella EUA describes FDA’s November 15, 2021 authorization for certain laboratory-developed RT-PCR SARS-CoV-2 tests using anterior nasal specimens for serial testing programs, including optional pooled testing and screening of asymptomatic individuals at least weekly. It specifies eligibility criteria, pooling parameters that vary by appendix (pool sizes up to 10, media vs. swab pooling, and possible home collection), and limits use to the single CLIA-certified high-complexity laboratory that developed the test. It also explains the notification/self-certification process for being added to Exhibit 1 and notes that listing does not necessarily mean FDA reviewed the underlying validation data.


CONTENT

On November 15, 2021, the FDA issued an umbrella EUA for certain RT-PCR molecular-based tests, developed by laboratories, for detection of nucleic acid from SARS-CoV-2 from anterior nasal respiratory specimens for use as part of a serial testing program, that meet certain criteria for eligibility specified in the EUA. Under this EUA, authorized tests can be used 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. This means that tests authorized by this EUA may be used with individual or pooled anterior nasal respiratory specimens from individuals with or without known or suspected exposure to COVID-19 when such individuals are tested at least once per week, such as testing at regular intervals as part of a testing program implemented by schools, workplaces, or community groups. The indications in each appendix (A-K) differ in the number of specimens that can be pooled (1, up to 3, up to 5, or up to 10), the type of pooling that can be done (media pooling or swab pooling), and whether the test can be used with home collected specimens.

Use of tests authorized by this EUA is limited to use in the single laboratory that developed the authorized test and that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meets requirements to perform high complexity tests. 

Tests will be added to Exhibit 1 of this EUA following submission of a complete notification to the FDA with the information required by the EUA, including self-certifying that the applicable validation has been completed, and confirmation by the FDA that the required documentation has been submitted. 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.

[EUA Letter of Authorization - Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing](https://www.fda.gov/media/154111/download?attachment)
[Appendix L - Fact Sheet for Health Care Providers (Template)](https://www.fda.gov/media/154112/download?attachment)
[Appendix M - Fact Sheet for Patients (Template)](https://www.fda.gov/media/154114/download?attachment)
[Appendix N - Test Summary (Template)](https://www.fda.gov/media/154113/download?attachment)