FDA to Shift Focus to International Standard, Replacing Quality System Regulation


Posted May 10, 2018

In a move of considerable significance for the manufacturers of medical devices, the Food and Drug Administration (FDA) announced Wednesday that it intends to replace the Quality System Regulation (21 CFR 820) with the specifications found in the international quality management standard ISO 13485:2016.

The widely anticipated announcement is part of a broader regulatory overhaul of sorts unfolding across the globe for the medical device industry, and its timing coincides with efforts by AAMI to revamp its programs to provide manufacturers with the guidance they need in this changing landscape.

“AAMI is working with industry stakeholders and other organizations, such as the Medical Imaging & Technology Alliance, AdvaMed, and the Medical Device Manufacturers Association, to minimize the hurdles that medical device manufacturers, especially smaller companies, will face during the transition from the Quality System Regulation to regulatory use of 13485,” said Joe Lewelling, AAMI’s vice president of emerging technologies and health IT.

A proposed rule from the agency describes the shift as part of an effort to “harmonize and modernize” the regulation of medical devices, a sentiment echoed by FDA Commissioner Scott Gottlieb.

“This will harmonize domestic and international requirements and modernize the regulation to make it more efficient for manufacturers seeking to sell their products globally, while also continuing to ensure they adhere to high, internationally-accepted quality systems,” Gottlieb wrote in a blog post.

The FDA hinted at a possible change in the way it oversees quality systems in March during the International Conference on Medical Device Standards and Regulations hosted by AAMI in collaboration with BSI and the FDA.

“There are a lot of similarities between the requirements of the Quality System Regulation and the clauses of 13485:2016,” said Keisha Thomas, deputy director of the division of premarket and labeling compliance in the FDA’s Center for Devices and Radiological Health. “Because they are so closely aligned right now, there is strong interest from the agency for some type of utilization and use of 13485.”

Anticipating a change in the way the FDA approaches quality oversight, AAMI has already updated its Quality System Requirements and Industry Practice course to include ISO 13485:2016 in addition to 21 CFR 820.

“Our relationship with the FDA helps us to anticipate and understand changes in the regulatory environment,” said Deborah Reuter, senior vice president of education at AAMI. “We develop our courses and training programs to provide professionals in the medical device industry with the latest and best guidance so that they can successfully navigate the regulatory terrain and see their companies grow.”

The FDA’s Gail Rodriguez and Melissa Torres will discuss the proposed changes and potential pathways forward during the AAMI/BSI International Conference on Medical Device Standards and Regulations in London, June 19–20.