AAMI News July 2018

Standards Spotlight: Preparation Begins as FDA Shifts Focus to Quality Management Systems Standard

In a move of considerable significance for medical device manufacturers, the Food and Drug Administration (FDA) announced in May that it intends to replace the Quality System Regulation (21 CFR 820) with the international quality management systems standard ANSI/AAMI/ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

This proposed change is part of a broader regulatory overhaul of sorts unfolding around the world for the medical device industry, and its timing coincides with efforts by AAMI to revamp its programs and resources to provide manufacturers with the guidance they need to navigate this changing regulatory landscape.

“AAMI is working with industry stakeholders and other organizations, such as the Medical Imaging & Technology Alliance (MITA), AdvaMed, and the Medical Device Manufacturers Association (MDMA), 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 Step toward Harmonization

The FDA’s proposed rule described 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.

Although there are a lot of similarities between the regulation and the standard, “the two are harmonized but not aligned,” according to Rob Menson, owner and manager of Menson & Associates, a Sarasota, FL–based consulting firm.

“There are no conflicts in requirements, but the requirements are not always identical or similar,” said Menson, who serves as an AAMI University faculty expert. “In many cases the standard has more specific requirements than the regulation (e.g., design and development planning, design verification, and design validation); however, the detail required by the standard is often included in companies’ execution and, in my experience, expected by the FDA.”

Making the Shift

So how much change will this regulatory shift cause? It depends on the manufacturer, according to experts. “A lot of medical device companies are there already,” said Jack Ward, owner of Ward Sciences and Consulting, LLC. This includes Philips, according to Dave Osborn, the company’s senior manager of international standards. “We have complied with 13485 for years—although some of our business still needs to transition from the previous version to the new (current) version,” he noted.

The same might not be true for smaller companies, though. “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.”

Updated QMS courseSupport during the Transition

Stakeholders from across the medical device industry, including AAMI, AdvaMed, MITA, and MDMA, are collaborating to provide support for this upcoming regulatory change, identify and address any hurdles, and develop resources to assist stakeholders, especially small- and medium-sized enterprises, according to Lewelling.

One such resource is a technical information report (TIR) being developed by AAMI that will map the requirements found in 13485 to 21 CFR 820. Publication of this new TIR is anticipated by the end of the year.

Over the next few months, a value proposition to support the proposed change also will be developed and published, as well as additional information and tools to assist stakeholders during the transition, Lewelling said.


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