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 [...]

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 [...]

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 [...]

With the February 2, 2026, implementation date for FDA’s Quality Management System Regulation (QMSR) quickly approaching, FDA has now issued a final rule making 179 technical amendments across Title 21 of the Code of Federal [...]

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 [...]