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COVID-19: FDA Device Guidance, Viral Mutation Updates

Ahead of the COVID-19 public health emergency (PHE) expiration on May 11, the Food and Drug Administration (FDA) on March 27 released final guidance on transitioning to normal operations for medical devices subject to enforcement policies and emergency use authorizations (EUAs) established during the PHE.

Affected devices will have a 180-day transition period. The enforcement policy guidance outlines a phased transition approach to normal operations, including recommendations on:

  • Developing a transition implementation plan.
  • Submitting a marketing submission.
  • Taking other actions with respect to these devices.

While a recently amended declaration established that EUAs will remain effective until there is no longer a “significant potential” for a COVID-19 PHE, FDA urges manufacturers of devices authorized under EUAs to begin planning their post-EUA regulatory and disposition strategies now.

FDA Updates SARS-CoV-2 Viral Mutations Page

As SARS-CoV-2, the virus that causes COVID-19, continues to evolve, FDA is monitoring the effect of new subvariants on COVID-19 test performance. FDA added Xtrava Health’s SPERA COVID-19 Ag Test to its list of tests expected to have reduced performance with certain omicron subvariants. The agency recommends that health care providers consult Xtrava’s “results and interpretation” tables and refer to the Antigen EUA Revisions for Serial (Repeat) Testing for updates to the authorized uses regarding the need for serial testing.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Faridat Animashaun is a policy associate at America's Essential Hospitals.

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