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FDA to Harmonize Quality System Requirements for Medical Devices through Adoption of ISO Management Standard


U.S. Chairs ISO TC 210, Committee That Developed ISO 13845

In an effort to harmonize and modernize the quality system regulation of medical devices, the U.S. Food and Drug Administration (FDA) has announced its intention to adopt the specifications of ISO 13485, an international consensus standard for medical device manufacture developed by the International Organization for Standardization (ISO). The revisions, which will replace the FDA's existing quality system (QS) requirements, are intended to reduce compliance and recordkeeping burdens on device manufacturers through the harmonization of domestic and international requirements.

ISO 13485:2016, Medical devices-Quality management systems-requirements for regulatory purposes, was developed by ISO Technical Committee (TC) 210, Quality management and corresponding general aspects for medical devices. The U.S. holds the secretariat of this committee, and the American National Standards Institute, the U.S. member of ISO, has delegated leadership responsibilities to the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer. AAMI is also the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator for this TC.

"This recognition is a further step in global harmonization of regulatory requirements for quality management systems in the medical devices sector," said TC 210 secretary Wil Vargas of AAMI.

The committee chair, Dr. P.W. Linders, added that if implemented by the FDA, "ISO 13485 would gain further recognition as the foundation for e?ective implementation of the medical devices single audit program (MDSAP), which is currently operated between Australia, Brazil, Canada, Japan, and the USA."

For more information, read the FDA announcement.

ISO 1345:2016 is also available in these packages on the ANSI Web store:


Jana Zabinski

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Beth Goodbaum

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