RAPS

FDA to Release ‘Emerging’ Safety Info on Devices

As the US Food and Drug Administration (FDA) looks to catch signals of medical device safety issues earlier to prevent adverse events, the agency has put out draft guidance outlining how it will track ...
RAPS

FDA to Publicly Disclose ‘Emerging Signals’ Info for Medical Devices

The public will soon see more prompt notifications on medical device risks and potential risks thanks to guidance finalized Tuesday by the US Food and Drug Administration (FDA). Under the guidance, ...