Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability Office (GAO) report only strengthens that conclusion.

FDA plans to fully integrate the use of artificial intelligence (AI) internally across all FDA centers by the end of June, following the completion of a generative AI pilot for scientific reviewers.