In Vitro Diagnostics EUAs | FDA

In Vitro Diagnostics EUAs | FDA

COVID-19 Update: FDA Provides Additional Recommendations for Validation of Sample Pooling

The U.S. Food and Drug Administration (FDA) updated the Molecular Diagnostic templates on FDA.gov to provide more detailed recommendations for the validation of assays intended to be used for pooling patient samples. Laboratories and commercial manufacturers may choose to use the Molecular Diagnostic templates to simplify the preparation and submission of an Emergency Use Authorization request for molecular SARS-CoV-2 assays intended to be used for pooling patient samples.

Read More Questions? If you have questions about asymptomatic testing and sample pooling, contact COVID19DX@fda.hhs.gov.