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.

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.