Communications Pilot to Enhance Medical Device Recall Program
The pilot aims to minimize the time between the FDA’s initial awareness of and public notification of potentially high-risk medical device removals or corrections.
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
The pilot aims to minimize the time between the FDA’s initial awareness of and public notification of potentially high-risk medical device removals or corrections.
Did you know that there are several over-the-counter (OTC) COVID-19 tests that have extended expiration dates? If you have at-home OTC COVID-19 tests with extended expiration dates, they can be used beyond the expiration date that is printed on the box.
The Center for Devices and Radiological Health (CDRH) is piloting device trial participation snapshots to highlight certain information about the intended uses of the device, its benefits and risks, and the diversity of participants in clinical trials for certain new medical devices.