FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.

The FDA announced that it removed a limitation on the use of real-world evidence (RWE) in drug and device application reviews ...

The FDA rarely uses its authority to pull dangerous medical devices off the market and is so poorly staffed that it's ...

The Illinois lawmakers want an electronic format for medical device makers to quickly and transparently report recall ...

FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government Accountability Office said.

FDA loses two key leaders as Jessica Paulsen departs Digital Health Center and David McMullen joins Neuralink amid staffing ...

FDA is removing barriers to real-world evidence in device applications, allowing the use of de-identified patient data from ...

Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.

The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...