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’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 May 29, 2026, FDA issued its final guidance, “Content of Human Factors Information in Medical Device Marketing Submissions.” The guidance provides a risk-based framework for determining what human factors information should be documented and [...]

FDA just gave the industry a very clear signal about AI in a cGMP environment. In an April 2, 2026 Warning Letter to Purolea Cosmetics Lab, FDA included a section on “Inappropriate Use of Artificial [...]

On April 16, 2026, FDA’s Center for Devices and Radiological Health (CDRH) issued a Letter to Industry warning manufacturers of CDRH-led combination products about the potential for nitrosamine impurities and outlining what manufacturers should be [...]

On February 18, 2026, FDA leadership signaled a major shift in how effectiveness is demonstrated for most drugs: the default expectation will be one adequate and well-controlled pivotal study, paired with confirmatory evidence, rather than [...]