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 September 9, 2026, FDA’s Center for Devices and Radiological Health (CDRH) hosted the first of three town halls focused on biocompatibility and medical devices. This first session focused on recent updates to ISO 10993-1:2025, [...]

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 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 [...]

Across medical device and IVD inspections, U.S. Food and Drug Administration (FDA) continues to issue Form 483 observations and Warning Letters tied to risk management failures. These findings are not about missing templates, they reflect [...]