METADATA
last updated: 2026-03-04 by BA
file_name: 2021-09-23_FDA Website - Revision Concerning Viral Mutations.md
file_date: 2021-09-23
title: FDA Website - Revision Concerning Viral Mutations
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: 435
words: 284
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#Revision
summary_short: The Revision Concerning Viral Mutations summarizes FDA’s September 23, 2021 update to certain molecular, antigen, and serology COVID-19 test EUAs adding new Conditions of Authorization to address emerging SARS-CoV-2 variants. It requires EUA holders to monitor viral mutations for potential performance impacts, communicate identified risks to FDA and end users, and update and submit revised labeling within three months. The change was intended to reduce false negatives linked to decreased sensitivity or non-reactivity from new mutations, with specific exclusions for some EUA categories.


CONTENT

On September 23, 2021, the FDA revised the EUAs of certain molecular, antigen, and serology tests to establish additional Conditions of Authorization in response to the continued emergence of new variants of SARS-CoV-2. The revision requires test developers to update their authorized labeling and evaluate the impact of SARS-CoV-2 viral mutations on their test's performance as outlined in the letter. This revision is effective as of September 23, 2021 for all EUAs that are within the scope of the revision. This revision does not apply to EUAs for authorized IL-6 assays or standalone specimen collection devices and does not apply to EUAs that include substantially equivalent viral mutation conditions of authorization.

The FDA has determined that establishing additional conditions is necessary to mitigate the potential risk of false negative results due to either decreased sensitivity or non-reactivity associated with SARS-CoV-2 viral mutations. As set forth in the September 23, 2021 letter, developers of authorized tests that are within the scope of the revision are now required to routinely monitor emerging viral mutations and their potential impact on the performance of the authorized SARS-CoV-2 test(s).  If potential impacts are identified, the EUA holder must communicate with the FDA and end users about the potential risk that presence of the mutations may have on test performance. The EUA holder must also update their authorized labeling consistent with the revision letter and submit the labeling to the FDA within 3 months of September 23, 2021. By taking these steps, the FDA and the test developer can quickly act in response to the potential risks identified and, when applicable, share the findings on [SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests?utm_medium=email&utm_source=govdelivery). 

[Viral Mutation Revision Letter - September 23, 2021](https://www.fda.gov/media/152406/download?attachment)