On October 20, 2026, the FDA published new hypothetical case examples demonstrating how Predetermined Change Control Plans (PCCPs) can support modifications to medical devices, including devices that use machine learning and continuously evolving software. The [...]

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 closed out 2025 - and opened the door to 2026 - with a clear signal to digital health and medical device sponsors: real-world performance of digital technologies is no longer a future consideration, it’s [...]