On August 18, 2026, FDA issued a discussion paper seeking public feedback on how the agency should approach regulation of generative AI-enabled medical devices. The paper asks for input on risk assessment, premarket evaluation, postmarket [...]

FDA has been updating its eMDR System Enhancements page to give industry early notice of upcoming electronic Medical Device Reporting changes. These updates are especially important for high-volume submitters and companies using third-party applications to [...]

FDA’s Total Product Life Cycle Advisory Program (TAP) continues to expand, giving more medical device innovators the opportunity for earlier, more frequent engagement with FDA during development. As of FDA’s July 2026 TAP update, the [...]

On July 10, 2026, FDA issued a proposed rule that would modernize drug manufacturing registration requirements. If finalized, the rule would create a streamlined registration pathway for distributed manufacturing establishments operating under a hub-and-spoke model. [...]

FDA leadership has seen significant turnover in May 2026, including the resignation of FDA Commissioner Marty Makary, the appointment of Kyle Diamantas as Acting Commissioner, and a change at the top of CDER with Michael [...]

Combination products don’t usually fail because the science is weak, they fail because teams hit avoidable friction: the wrong lead center, unclear expectations across centers, duplicated information, and quality system gaps that surface late. Two [...]