Medical Innovation Exchange

FDA Adopts ISO 13485 with QMSR Final Rule



The FDA has issued the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule emphasizes risk management activities and risk-based decision making and aims to reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements, specifically through the adoption of ISO 13485. The rule amends the current good manufacturing practice requirements of the Quality System regulation in 21 CFR 820.

“This final rule is the latest action taken by the FDA to promote global harmonization in device regulation to help assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices both at home and abroad,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “By harmonizing key areas of a medical device manufacturer’s quality management system with the international standard, the FDA is streamlining actions device manufacturers must take to meet requirements by multiple regulatory authorities.”

The FDA estimates that the QMSR will result in an annualized net cost savings of more than $500 million, while allowing for quicker access to newly developed medical devices for patients leading to improved quality of life of the consumers.

Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Until then, manufacturers are required to comply with the existing Quality System regulation.

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