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 [...]

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 [...]

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 [...]

In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]