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 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.

Five months into FDA's new Quality Management System Regulation, the agency has said out loud what's actually showing up in QMSR Form 483 findings — and it's not a paperwork problem.