On February 2, 2026, FDA’s revised 21 CFR Part 820 - now titled the Quality Management System Regulation (QMSR) - became effective. The key change is that FDA now incorporates ISO 13485:2016 by reference as [...]

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 [...]

If you want to know where regulatory expectations are headed, you don’t always need a new guidance document. Sometimes you just need to listen to what regulatory pros keep arguing about. Across recent discussions, three [...]

The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now [...]

The FDA’s updated guidance on Unique Device Identification (UDI) for combination products, updated as of June 2025, has stirred conversation across the industry. For companies developing products that merge drug, biologic, and device components, labeling [...]