How many days after August 1st, 2020, will the FDA issue an Emergency Use Authorization for a product that performs some form of COVID testing directly in the home, meaning sample collection, molecular biology, and diagnostic result delivery can all be done without a user leaving their home?
Access to cloud computing is fine. Tele-guidance from a trained healthcare practitioner or anyone else is fine.
How many days after August 1st, 2020, will the FDA issue an Emergency Use Authorization for a product that performs some form of COVID testing directly in the home, meaning sample collection, molecular biology, and diagnostic result delivery can all be done without a user leaving their home?
Access to cloud computing is fine. Tele-guidance from a trained healthcare practitioner or anyone else is fine.
Context:
1. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev