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

The Food and Drug Administration wants the developers of medical devices that rely on artificial intelligence to disclose much more detail about how their devices were developed and tested ...

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.

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.

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

The Food and Drug Administration is aiming to help developers of artificial intelligence-enabled medical devices understand the agency's mindset around the technology. The agency announced Monday ...

Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation "The FDA has authorized more ...