CDRH Archives - Quality Solutions Now (QSN)

FDA’s New Change Control Examples: Why Device Modifications Need a Plan Before They Happen
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 [...]
FDA Town Hall Takeaways: Biocompatibility Risk Assessment and ISO 10993-1:2025
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, [...]
Nitrosamines in CDRH-Led Combination Products
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 [...]
FDA Launches Communications Pilot to Accelerate High-Risk Medical Device Recall Notifications
In a move aimed at strengthening patient safety and enhancing transparency, the FDA’s Center for Devices and Radiological Health (CDRH) has announced a new communications pilot program that seeks to reduce the time between the [...]