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FDA to Expand Use of AI in Scientific Reviews

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.

FDA Expands Unannounced Inspections of Foreign Manufacturing Facilities

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.

FDA to Address Data Integrity Concerns with China-Based Third-Party Testing Labs

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.

FDA to Phase Out Animal Testing Requirements for Drugs

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.

FDA Struggles to Meet Product Review Deadlines

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.
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FDA Warns Against Unauthorized Modifications to Medical Devices

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.

FDA Alerts the Medical Device Industry About Unreliable Third-Party Test Data

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.

FDA Issues Draft Guidance on AI-Based Medical Devices

The FDA releases landmark draft guidance for AI-enabled medical devices, offering manufacturers a roadmap for development, approval, and lifecycle management while addressing critical concerns of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

Med Device Company Pays $175m Penalty for Misleading Investors Over Compliance Issues

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.

FDA Publishes Updated Guidance on Global Unique Device Identification Database (GUDID)

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