George Tidmarsh is taking on more responsibilities at FDA after the sudden departure of top official Vinay Prasad.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

As noted above, this week FDA also released new draft guidance on the use of AI to support regulatory decision-making for drugs and biological products, and for AI-enabled medical device software ...

The FDA stands as a robust guardian of patient safety and quality standards within the medical device industry. Through stringent regulatory processes, it ensures that only safe and effective ...

SBOMs And The Future Of Medical Device Cybersecurity Compliance and regulations can support product development in a positive way. The FDA mandate fits in this category.

On October 3, the U.S. Food & Drug Administration (FDA) published a highly anticipated proposed rule (Proposed Rule) to regulate laboratory-developed tests (LDTs) as medical devices. LDTs are ...

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most late reports filed more than six months after manufacturer notifications ...

Perspectives > Second Opinions How Much Do Physicians Really Know About FDA Drug and Device Regulation? — More education is clearly needed by Sanket S. Dhruva, MD, MHS, Aaron S. Kesselheim, MD ...

This same concept is uniquely suited to the regulation of artificial intelligence (AI) medical devices that can augment patient care. Legislation currently before Congress (Senate Bill 2209 and ...

An overview of the legal framework and policies for marketing and advertising drugs and medical devices (medical products) regulated by the US Food and Drug Administration (FDA).