Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff

Name: Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff
Creator: Food and Drug Administration
Keywords: coronavirus,covid,covid-19,fda,guidances,impact,mutations,policies,sars-cov-2

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Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

January 12, 2023

Last updated

March 24, 2023

Description

Revised policy providing guidance for evaluating impact of viral mutations on COVID-19 tests, aimed at test developers and FDA staff.

Organization

Food and Drug Administration (FDA) 🇺🇸

Country / Region

United States

License

Other (Public Domain)

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Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff

Updated on March 24, 2023

pdf (430.3KB)

URL: https://www.fda.gov/media/146171/download
Permalink: https://data.openrid.co/en/datasets/r/16ea7bc4-ea2a-4095-b682-91c684d5c338
MIME Type: application/pdf

Created on: January 12, 2023
Modified on: March 24, 2023

Size: 430.3KB

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff

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