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 ...
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 ...
JD Supra

COVID-19 Related Medical Devices: FDA Finalizes Transition Plan Guidance

On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies ...
BioWorld

FDA: Imaging agents to transition from drugs to devices

Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at ...
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, ...