The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations. The Biden Administration plans to end the COVID-19 PHE declaration on May 11. The COVID-19 EUA declaration for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will remain in effect until there is no longer a “significant potential” for a COVID-19 PHE or the authorized devices or products have been approved. 

Related News Articles

Headline
The Food and Drug Administration Dec. 31 released an alert highlighting a Baxter letter that recommended health care providers not use certain lots of Solution…
Headline
The Food and Drug Administration yesterday released recommendations for streamlining the approval process for medical devices that use artificial intelligence…
Headline
The Centers for Disease Control and Prevention last week endorsed a recommendation for people aged 65 and older and for immunocompromised individuals to…
Headline
The Centers for Medicare & Medicaid Services Oct. 22 released final guidance detailing reporting requirements for the hospital respiratory data condition…
Headline
The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-…
Headline
The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been…