March 29 Update - FAQs on Test Development for SARS-CoV-2

New Test Development and Review FAQ gives details about leveraging validation data on the adequacy of pediatric self-swabbing.

If your email program has trouble displaying this email, view as a webpage. March 29 Update: Added Information on Leveraging Validation Data on the Adequacy of Pediatric Self-Swabbing for COVID-19 Testing The FDA recently added information about leveraging validation data from a study on the adequacy of pediatric self-swabbing to collect a sample for COVID-19 diagnostic testing. The new information is found at COVID-19: Test Development and Review and includes: ADDING the following question and answer: I want to offer my COVID-19 diagnostic test for pediatric self-swabbing. Is validation data available to leverage to support this indication? UPDATING the following question and answer: Can I leverage validation data that has already been reviewed by the FDA for another test? FAQs on Testing Questions? Email CDRH-EUA-Templates@fda.hhs.gov

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