Yesterday, FDA's Digital Health Center of Excellence published something it was careful to call a discussion paper rather than guidance: a 30-page document laying out considerations for regulating generative AI-enabled medical devices, opening a public comment docket that runs until October 19. The agency has been explicit that this isn't draft policy — it doesn't propose regulatory expectations, doesn't address whether new legal authority would be needed, and doesn't commit

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's voluntary Quality Management Maturity Program is quietly building toward a real quality rating system. Here's what it measures and what's at stake.

FDA decides Aug 5 on Moderna's mRNA-1010 flu vaccine. Here's the trial data, the competitive landscape, and why the decision matters beyond flu shots.

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.

In February 2008, hospitals across the United States began seeing something that almost never happens with heparin, a blood thinner used in millions of procedures every year: patients going into sudden, severe allergic-type reactions — hypotension, nausea, shortness of breath — within minutes of receiving it. The FDA would eventually trace the cause to a contaminant called oversulfated chondroitin sulfate, added somewhere upstream in the crude heparin supply chain in China, a

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.