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As noted above, this week FDA also released new draft guidance on the use of AI to support regulatory decision-making for drugs and biological products, and for AI-enabled medical device software ...

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 ...

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

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 ...

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

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 ...

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.

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 ...