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 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 [...]

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 [...]

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 [...]

FDA closed out 2025 with a meaningful update for device sponsors: the final guidance, “Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices,” issued December 18, 2025, which supersedes the prior 2017 [...]