FDA retired QSIT, its 30-year device inspection framework, on Feb 2, 2026. Here's what the new QMSR-aligned, risk-based process means for your audits.

FDA's final Human Factors guidance takes effect this week. Here's what changed in the eSTAR template and what to check in your submission pipeline now.

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.