On August 5, FDA held a public meeting to walk through its proposed recommendations for reauthorizing the Medical Device User Fee Amendments — MDUFA VI — the negotiated agreement that will determine how FDA's device review program is funded and how fast it moves for fiscal years 2028 through 2032. That meeting matters because of what preceded it: FDA and industry, represented by AdvaMed and the Medical Device Manufacturers Association, had already reached an agreement in prin

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.

FDA just closed one of the more debated gray areas in device submissions — and industry has one week to get ready for the follow-up discussion. On May 29, FDA finalized its guidance on Human Factors information in device marketing submissions, replacing the 2022 draft.