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FDA Compliance

FDA Plans to Use ISO 13485 for Medical Devices Regulation

Intended to harmonize domestic and international requirements

Published: Wednesday, August 29, 2018 - 11:00

(ISO: Geneva) -- The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its intention to use ISO 13485 as the basis for its quality system legislation.

The International Organization for Standardization’s (ISO) international standard, ISO 13485: Medical devices—Quality management systems—Requirements for regulatory purposes, is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.

The ISO technical committee (TC) 210 warmly welcomes the FDA’s planned adoption. ISO/TC 210, responsible for the quality management and corresponding general aspects for medical devices, is run by the American National Standards Institute (ANSI), ISO’s member in the United States.

“This announcement will take global harmonization of regulatory requirements in the medical devices sector to a next level,” says Wil Vargas of the Association for the Advancement of Medical Instrumentation (AAMI), and secretary of ISO/TC 210.

“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,” adds Peter Linders, chair of ISO/TC 210.


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The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a nongovernmental organization that forms a bridge between the public and private sectors. ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. View the ISO Standards list.


ISO 13485 -third revision.


I have a question for (and may be a request to) the committee TC 210.

Why has this standard not been harmonised to the HLS-high level structure-adopted by the ISO for all its standards.

I  would request that this be promptly done so that the medical devices manufacturers can also get advantages of requirements like context, risk based thinking and many other new characteristics of the HLS.


virendra gupta