FDA Details Plan To Phase Out COVID-Related Medical Device Policies

By Beth Wang / March 28, 2023 at 1:14 PM
FDA will follow a three-step plan to phase out some temporary medical device enforcement policies that were issued during the COVID-19 public health emergency, the agency announced in final guidance published Friday (March 24), a little more than a month before the planned PHE ends on May 11. FDA will apply its phase-out approach to 15 COVID-19-related guidances, including those that establish temporary enforcement policies for the use and distribution of digital health and remote monitoring devices and personal protective...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.