Now that the nation has transitioned out of the emergency phase of the COVID-19 pandemic, top officials at the US Food and Drug Administration’s (FDA) device center say they have seen a “resurgence” ...

Officials from the US Food and Drug Administration (FDA) discussed strategies for integrating artificial intelligence (AI) ...

While receiving more than 19,000 product submissions during 2023, CDRH granted marketing nods to 124 novel devices—covering premarket approvals and de novo clearances, but not counting COVID-era ...

The sudden firing of Food and Drug Administration employees over the weekend is already affecting medical device submissions. The cuts could delay the time it takes to bring new products to market and ...