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
U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co.…
Headline
The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19…
Headline
Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired…
Headline
In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an…
Headline
On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a webinar to review its recent proposed rule for laboratory developed tests,…
Headline
The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12 by unanimous vote declared oral phenylephrine…