FDA Website - Umbrella EUA for Independently Validated Serology Tests
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.
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2020-04-28_FDA Website - Umbrella EUA for Independently Validated Serology Tests.md
regulatory/fda-policy/2020-04-28_FDA Website - Umbrella EUA for Independently Validated Serology Tests.md
2020_04_28
date converted 2024-04-05
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