FDA to use ISO 13485 as basis for revamped quality system legislation

August 29, 2018

When I started reporting on the medical manufacturing supply chain back in 1996—a job that many years later segued into my current gig at PlasticsToday—regulatory harmonization was an industry buzzword. Incremental progress has been made over the years, the key word here being incremental. The pace of change in medical device regulations has been justifiably qualified as glacial, but even glaciers shift over time. The announcement by FDA that it will use ISO 13485 in replacing its current quality system regulation has been touted by the International Organization for Standardization (ISO; Geneva, Switzerland) as taking “global harmonization of regulatory requirements in the medical devices sector to a next level.”

Image courtesy ISO.

"ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes," is the international standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in an efficient and transparent manner, said ISO in a press release. The standard, which is now in its third edition, received strong support from FDA, in line with its drive for global convergence of medical device regulatory processes, noted ISO.

The American National Standards Institute (ANSI; Washington, DC), ISO’s U.S. member, runs ISO/TC 210, the technical committee responsible for quality management and related issues involving medical devices. It “warmly welcomed” the planned adoption of ISO 13485. “This bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated by Australia, Brazil, Canada, Japan and the USA,” said committee Chair Peter Linders.

In addition to a reduced regulatory burden, harmonization is expected to play a role in attracting a greater number of device companies to the United States, reported Regulatory Focus, the media outlet of the Regulatory Affairs Professional Society (RAPS; Rockville, MD) "In theory, a company that is compliant with ISO 13485 outside the U.S. should have an easier time and [reduced financial burden] aligning their compliance to enter the U.S. market," Wil Vargas, Director of Standards at AAMI, told Regulatory Focus. The new rule making, therefore, may help "more companies to more easily" bring their products to the U.S., Vargas added.

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