diagnostic

FDA updated its FAQ document

May 14, 2020

McDermott+Consulting

FDA continues to regularly update its FAQ regarding COVID-19 testing.

In terms of EUAs, the FDA has issued 75 for commercial laboratories and/or manufacturer test kits. It has also issued 28 EUAs for high complexity, molecular based LDTs.

Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

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