METADATA
last updated: 2026-03-04 by BA
file_name: 2020-04-28_FDA Website - Umbrella EUA for Independently Validated Serology Tests.md
file_date: 2020-04-28
title: FDA Website - Umbrella EUA for Independently Validated Serology Tests
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: 271
words: 181
notes: date converted 2024-04-05
web_url: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-emergency-use-authorizations-euas-serology-and-other-adaptive-immune-response#umbrella-serological
summary_short: The Umbrella EUA for Independently Validated SARS-CoV-2 Serology Tests describes FDA’s April 28, 2020 authorization pathway for antibody tests validated through designated government studies such as NIH/NCI. It explains that no tests were ultimately authorized under this umbrella and that FDA revoked the EUA on July 21, 2020 in favor of issuing individual EUAs with test-specific conditions and broader, more flexible scopes of authorization.


CONTENT

On April 28, 2020, FDA issued an umbrella EUA for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health's (NIH) National Cancer Institute (NCI), or by another government agency designated by the FDA, and are confirmed by the FDA to meet the criteria set forth in the Scope of Authorization of the EUA.  To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.

On July 21, 2020, FDA determined, based on information and experience since issuing this EUA, that circumstances support revocation of this umbrella EUA so that FDA may issue individual EUAs. Individual EUAs will allow for broader indications and scopes of authorization, individualized conditions of authorization to address any issue unique to a specific test, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA.

Accordingly, [the EUA was revoked](https://www.fda.gov/media/140351/download?attachment) under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.