FDA Details Post-COVID Transition Guidelines For EUA Devices

By David Jensen

The FDA has begun making preparations for med device companies to return to post-Covid-19 normal regulatory processes after the EUA status of their devices expires. The FDA’s Center for Devices and Radiological Health (CDRH) has provided details about two new guidances it has drafted, which explain how med device manufacturers should plan to transition away from EUA.

In short, the agency is proposing to give medical device makers advanced notice of 180 days before terminating the company’s EUA status and replacing its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).

Here we review the EUA transition guidances in more detail and share insights from a recent FDA online training that was held to help prepare medical device manufacturers and other stakeholders for an orderly and transparent transition to normal regulated operations.