FDA issues QMSR final rule with 2-year transition period

The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with a widely recognized International Organization for Standardization (ISO) standard. 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, 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 come into 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.

FDA first developed its QS regulation in 1996 to establish requirements for controlling and operating medical device manufacturing facilities. It also detailed requirements for designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices. That same year, ISO published the first version of ISO 13485, which has significantly evolved over the years. With the latest update to the standard in 2016, FDA says its QS and ISO’s standard are much more closely aligned.

“Recognizing this progression, FDA sees an opportunity for regulatory harmonization by amending part 820 to incorporate by reference the QMS requirements of ISO 13485 and, thereby, replace the QS regulation with the new QMSR,” said the agency. “ISO 13485 is used internationally by many regulatory authorities either as a foundation for or as that regulatory authority’s QMS requirements for device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP), in which FDA and regulatory authorities from four other countries participate.”

While QS has been effective in addressing FDA’s QMS requirements, the agency said it doesn’t have the detailed requirements that it would like to see when sponsors propose how to design and manufacture medical devices. FDA says the QMSR intends to provide that kind of detail while harmonizing its work across regulatory regimes.

“The FDA has traditionally expected manufacturers to integrate risk management activities throughout their Quality Management System (QMS) and across the total product lifecycle,” FDA spokesperson Kristina Wieghmink told Focus. “The FDA discussed risk management and risk-based decision-making in the 1996 Final Rule establishing the current QS requirements.”

“The QS regulation explicitly addressed risk management activities in § 820.30(g) (21 CFR 820.30(g)),” she added. “In adopting ISO 13485, the QMSR incorporates risk management throughout its requirements and explicitly emphasizes risk management activities and risk-based decision making as important elements of an effective quality system.”

Wieghmink noted that FDA does not consider the QMSR as additional requirements being added to its QS, but rather that the requirements are now more explicitly incorporated into the regulations. She added that rather than adding new requirements, the rule has reorganized and changed the wording of requirements to better align with the agency’s expectations.

FDA said the update also doesn’t create any inconsistencies with other applicable regulatory requirements, and it has clarified device Quality Management System (QMS) requirements for combination products, but they do not affect CGMP requirements for combination products.

Besides streamlining good manufacturing requirements across regulatory regimes, FDA also expects the harmonization will save the medtech industry hundreds of millions of dollars each year. The agency estimates the rule will save about $532 million annually at a 7% discount rate and $554 million annually at a 3% discount rate.

It also expects the rule will align with other regulatory-related programs that could lead to additional cost savings for industry.

“FDA believes the global harmonization of medical device regulation can help provide safe, effective, and high-quality devices and contributes to public health through timelier patient access to such devices,” said FDA. “Harmonizing differing regulations removes unnecessary duplicative regulatory requirements and impediments to market access and removes barriers to patient access and lowers costs.”

Wieghmink noted that QMSR may be updated in the future, but FDA would need to go through a rule-making process to evaluate the need and impact of any changes. In the meantime, the agency plans to take steps to ensure all stakeholders come up to speed on what is required of them under the new rule.

“The FDA intends to engage in a variety of implementation activities including, updating information technology systems, training FDA staff responsible for assessing compliance with medical device quality management system requirements, finalizing the inspection process, revising relevant regulations and other documents impacted by this rulemaking, and communicating and educating stakeholders on the change,” said Wieghmink.

Focus reached out to several stakeholders to get their take on the new rule, but they said they are still evaluating the rule. AdvaMed CEO Scott Whitaker told Focus that in principle the industry group supports FDA’s efforts to recognize and use international voluntary consensus standards to promote global harmonization.

“While we are still reviewing the contents of the final rule, we supported the proposed rule as an important step for global harmonization and were eagerly awaiting the release of the final,” he added. “We stand ready to collaborate with FDA to ensure a seamless implementation.”

QMSR final rule

FDA issues QMSR final rule with 2-year transition period

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