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 monitoring, foundation models, agentic AI systems, and other topics relevant to this rapidly evolving area. [...]

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 create eMDR submission files. FDA notes that these firms should use the information to plan [...]

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 program has expanded across all Offices of Health Technologies (OHTs) for qualifying Breakthrough-designated and Safer [...]

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 also says the rule would clarify registration requirements for certain foreign establishments that manufacture [...]