As of February 2, 2024, the U.S. Food and Drug Administration (FDA) published its new and final Quality Management System Regulation (QMSR), amending the good manufacturing practice requirements of the Quality System Regulation (QSR) for medical devices to align more closely with the international consensus standard ISO 13485:2016, Medical devices–Quality management systems–Requirements for regulatory purposes.
QMSR incorporates the internationally recognized quality management systems standard by reference, and FDA has proposed additional rules to ensure that the document aligns with existing FDA requirements.
“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.”
This publication of the FDA’s QMSR also marks the completion of a longstanding AAMI goal related to international harmonization.
“AAMI’s history of promoting ISO 13485 and referencing the document in our myriad of standards across the medical device space is a testament to the document’s importance and efficacy,” said Matthew Williams, vice president of standards, AAMI. “Making it THE global standard for quality systems requires major regulatory bodies to not only recognize but utilize the standard. The adoption of the new rule by the FDA will make this a reality for the U.S., taking us one crucial step closer to global harmonization.”
Reacting to the news, AAMI Vice President of Industry Joe Lewelling added that “this is a huge milestone and something the industry and AAMI have been working toward since AAMI proposed the establishment of the International Organization for Standardization Technical Committee 210 in 1994. The goal then was to promote global regulatory alignment around International Standards and ISO 13485 is arguably the most important standard in the entire body of international medical device standards.”
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.
The Right Time
Melissa Torres, associate director for international affairs at FDA’s CDRH noted that globally harmonized regulatory oversight will ease the path to global markets for device manufacturers, as many companies already comply with ANSI/AAMI/ISO 13485:2016/(R)2019, the U.S. adoption of the international standard.
According to the FDA, an easier path for manufacturers will also mean fewer costs for companies navigating the U.S. regulatory environment overall.
“We estimate that the QMSR will result in an annualized net cost savings of approximately $532 million … and approximately $554 million in annualized net cost savings,” the FDA announced within its Final Rule. “In addition to the cost savings to the medical device industry, the qualitative benefits of the rule include quicker access to newly developed medical devices for patients leading to improved quality of life of the consumers. The rule will also align part 820 with other related programs potentially contributing to additional cost savings.”
Of course, the transition may still be jarring for some. When the proposed rule was first announced, AAMI faculty and industry consultant Rob Menson warned that the differences between FDA’s QSR and ISO 13485:2016 were “harmonized but not aligned.”
“From my perspective, the small manufacturers that only participate in the U.S. market will not have the resources and perhaps not have the knowledge to make the shift easily,” Menson said. “The organizational structure of the standard is different from the Quality System Regulation, and this will take small organizations not familiar with it some time to digest and incorporate the changes into their quality system and practices.”
