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A Comprehensive Guide to COVID-19 EUA Submissions

TAGS: IVD Automation
Graphic by Amanda Pedersen A Comprehensive Guide to COVID-19 EUA Submissions
FDA is currently accepting COVID-19 emergency use authorization (EUA) requests for in vitro diagnostics, ventilators, and personal protective equipment. For a list of current EAUs related to the coronavirus pandemic or to download the most current EUA template, click here.
Step-by-step recommendations from FDA on how to seek emergency use authorization (EUA) for COVID-19 tests, ventilators, and personal protective equipment, plus answers to frequently asked questions.

Links for additional information:

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

Additional frequently asked questions about COVID-19 EUAs, including questions specific to clinical laboratories and questions specific to test kit manufacturers

If you have additional questions for FDA contact the Division of Microbiology Devices at 301-348-1778 or email CDRH-EUA-Templates@fda.hhs.gov

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