U.S. Food and Drug Administration (FDA)

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The FDA releases landmark draft guidance for AI-enabled medical devices, offering manufacturers a roadmap for development, approval, and lifecycle management while addressing critical concerns of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

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) is launching a pilot program to help speed the release of news and information regarding potentially high-risk medical devices.

The U.S. Food and Drug Administration (FDA) has published its final guidance on its third-party review program and its third-party emergency use authorization (EUA) review process.

The U.S. Food and Drug Administration (FDA) has released a helpful glossary of commonly used terms in connection with digital health devices and medical devices that use artificial intelligence (AI) or machine learning.

The FDA has classified a radiofrequency-based electric toothbrush as a medical device, establishing regulations to ensure the safety and effectiveness of this emerging dental technology.