JD Supra

FDA Issues Draft Transition Plans for Medical Devices Commercialized Pursuant to EUA or Enforcement Discretion Policy During COVID-19 Emergency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use ...
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 ...
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, ...
FierceBiotech

FDA outlines regulatory transition plan for COVID tests, devices as public health emergency wraps up

The FDA has laid down a path for the developers of COVID-19 tests and other pandemic-focused medical devices to finally make the transition to the foreseeable regulatory future, where the coronavirus ...