Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

In fact, FDA has begun to closely scrutinize their use — including by issuing Warning Letters — as further described herein. Medical Device Definition & FDA Enforcement Discretion In general ...

The guidance discusses "how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices," an FDA news release states.

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.