MD&M East

Practical Considerations for Draft Transition Plans for Devices Under EUAs or COVID Enforcement Policies

On Jan. 31, 2020, the Department of Health and Human Services (HHS) declared a public health emergency (PHE) related to the global COVID-19 pandemic. The declaration of a PHE enabled FDA to issue a ...
JD Supra

FDA transition plan for COVID-19 medical devices requests new submissions to agency

On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in ...
RAPS

Pharma, device groups oppose FDA's planned drug to device transition

Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated ...
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 ...
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, ...