Zdrowie i gospodarka · 17/11/2025

FDA Releases Draft Guidance on Quality Management System Information for Premarket Submissions Reviews

The FDA has released a draft guidance document titled 'Quality Management System Information for Certain Premarket Submission Reviews' to help FDA staff and medical device manufacturers understand the agency's expectations for quality management systems (QMS) in device submissions. The guidance is intended to align with the international consensus standard for device quality management systems, effective February 2, 2026.