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

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

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 ...

As noted above, this week FDA also released new draft guidance on the use of AI to support regulatory decision-making for drugs and biological products, and for AI-enabled medical device software ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

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 ...

The U.S. Food and Drug Administration said on Tuesday it will now review all imports of the products it regulates regardless ...

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.

The FDA considers devices approved through this “501 (k) pathway” to be moderate risk. The other 29%, seen as high-risk, followed a different pathway requiring clinical trials.

The U.S. Food and Drug Administration has authorized the sale of Juul Labs' e-cigarette device and refill cartridges in ...

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 ...