JD Supra

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance ...
JD Supra

FDA Issues Final Transition Guidances For COVID-19 Devices

These policies are all currently set to expire on November 7, 2023, which is 180 days after May 11, 2023. The Enforcement Policy Transition Guidance sets out three phases: Phase 1 (first 90 days after ...
Becker's Hospital Review

FDA finalizes PHE transition plan for medical devices

With the COVID-19 public health emergency set to expire May 11, the FDA is preparing to prevent any supply disruptions to medical devices after three years of shortages partly spurred by the pandemic.
Healthcare Dive

FDA details plan to end emergency use authorizations

With the COVID-19 public health emergency set to expire on May 11, medical technology companies that brought devices to market under special pandemic rules will need to prepare transition plans soon, ...