FDA publishes long-awaited QMSR

The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with the International Organization for Standardization (ISO) standard ISO 13485. The agency said the rule will ensure consistency in regulatory expectations for device makers across regulatory regimes, while saving industry hundreds of millions of dollars annually.

On 31 January 2024, FDA published its QMSR final rule that has been years in the making. The rule amends FDA’s current medical device good manufacturing practice (CGMP) expectations under its quality system (QS) regulation to align with ISO 13485:2016.

“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, director of FDA’s Center for Devices and Radiological Health (CDRH). “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.”

Industry has until 2 February 2026 to achieve compliance with the new rule and can continue to comply with requirements under the current QS regulation until then.

FDA said the requirements in ISO 13485 are substantially similar to those in its QS regulation, meaning that it provides a similar level of assurance that a medtech manufacturer’s quality management system is compliant with the agency’s regulatory expectations. With that in mind, the agency said the new rule retains the scope of the QS regulation while amending many of its provisions.

“We are also amending the title of the regulation and establishing additional requirements and provisions that clarify certain expectations and certain concepts used in ISO 13485,” the agency added.