A two-day public workshop on evaluating robotic surgery systems with autonomous or remote capabilities is also on the agency’s agenda, as telesurgery advances globally.

In January 2025, the FDA published the draft version of the guidance on lifecycle management for AI-enabled devices now ...

FDA movement of peptides toward 503A bulks listing advanced despite internal scientific objections citing absent human ...

The FDA has issued a final rule that would remove references to animal studies in its drug safety regulations, as part of a ...

Silver Spring, MD, Sept. 21, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used ...

The draft guidance outlines the testing and clinical evidence manufacturers should include when seeking authorization for ...

Federal authorization, FDA enforcement discretion, and state market access are three separate questions. A product can lack FDA authorization yet fall within FDA’s current enforcement priorities, ...

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...

After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed ...

Former White House AI & crypto czar David Sacks assesses the artificial intelligence regulation debate while exploring the ...