FDA's December 2025 final guidance on real-world evidence for medical devices removed a major barrier to using real-world data in submissions. What changed in 2026, and what device sponsors need to do differently to put RWE to work.

For thirty years, "checking MAUDE" has been shorthand for post-market vigilance in the medical device industry. It is the database regulatory teams cite in literature searches, the tool clinical affairs pulls up before a submission, the first stop for anyone trying to understand how a device is behaving once it leaves the controlled world of a clinical trial and enters the far messier world of actual patients. By the end of May 2026, it will not exist in its current form.