FDA authorizations for EUAs

by T. King

Share

FDAAs of June 10, 2022, The FDA has authorized 437 tests and sample collection devices under emergency use authorizations (EUAs). These include:

  • 302 molecular tests and sample collection devices
  • 85 antibody and other immune response tests
  • 49 antigen tests
  • 1 diagnostic breath test
  • 80 molecular authorizations
  • 1 antibody authorization that can be used with home-collected samples
  • 1 EUA for a molecular prescription at-home test
  • 2 EUAs for antigen prescription at-home tests
  • 17 EUAs for antigen over-the-counter (OTC) at-home tests
  • 3 for molecular OTC at-home tests.

The FDA has also authorized 27 antigen tests and 8 molecular tests for serial screening programs as well as authorizing 1000 revisions to EUA authorizations.

Please click on this FDA link to read this announcement on COVID-19 as well as many more announcements and updates!

Compliance Insight

T. King served as a regulatory compliance writer and content contributor at Compliance Insight, Inc., where she authored over 100 articles covering FDA compliance, GMP regulations, medical device requirements, pharmaceutical quality systems, and life sciences regulatory affairs. Her work supported Compliance Insight's mission of making FDA regulatory guidance accessible and actionable for life science professionals.