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The use of artificial intelligence (AI) tools is rapidly gaining traction throughout industries around the world. Now, the U.S. Food and Drug Administration (FDA) is stepping up to leverage the potential benefits of AI.

The U.S. Food and Drug Administration (FDA) is stepping up its use of unannounced inspections at foreign manufacturing facilities that produce medicines and other medical products.

The U.S. Food and Drug Administration (FDA) is raising concerns about the integrity of data submitted by two China-based testing laboratories in support of recent premarket medical device submissions.

The U.S. Food and Drug Administration (FDA) reports that it is taking action to reduce or eliminate animal testing in the development of certain categories of drugs and other medications.

Staff at the U.S. Food and Drug Administration (FDA) are reportedly struggling to meet application review deadlines for medical device and tobacco products due to recent staff reductions.

The U.S. Food and Drug Administration (FDA) is also stepping up its efforts to identify FDA-cleared medical devices that have been subsequently modified and that no longer fall within the scope of their original clearance.

The U.S. Food and Drug Administration (FDA) is advising medical device manufacturers to take steps to verify the accuracy and reliability of third-party testing data before submitting it to the FDA.

The FDA releases landmark draft guidance for AI-enabled medical devices, offering manufacturers a roadmap for development, approval, and lifecycle management while addressing critical concerns of transparency and demographic bias.

Medical device giant Becton, Dickinson to pay $175M SEC fine for concealing safety risks of its Alaris infusion pump, which generated 10% of company revenues. FDA clearance issues and software problems threatened future sales.

The FDA has overhauled its medical device tracking system, streamlining how manufacturers identify everything from pacemakers to surgical robots in a global database refresh.