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THE US FOOD AND MEDICINES ADMINISTRATION UU. (FDA), THE GOVERNMENT DEPARTMENT REGULATING THE MEDICAL DEVICES SECTOR ANNOUNCED ITS INTENTION TO USE THE ISO 13485 STANDARD AS THE BASE FOR ITS QUALITY SYSTEMS LEGISLATION.

ISO 13485, Medical devices - Quality management systems - Requirements for regulatory purposes, is the International Standard for quality management systems for the medical device sector. Published in 2016, it is designed to work with other management systems in an efficient and transparent way. 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 FDA announcement that it will use ISO 13485 to replace its current quality system regulation is an important next step in recognizing that this standard has already gained worldwide.

ISO / TC 210 welcomes the planned adoption of the FDA. This ISO technical committee, responsible for quality management and corresponding general aspects for medical devices, is managed by ANSI, an ISO member in the United States.

Wil Vargas of the Association for the Advancement of Medical Instrumentation (AAMI) and Secretary of ISO / TC 210 said that “this announcement will take the global harmonization of regulatory requirements in the medical device sector to a higher level” . The committee chairman, Peter Linders, added that “this bold step by the FDA seems logical, considering the role of ISO 13485 as the basis for the Single Medical Device Audit Program (MDSAP), currently operated by Australia, Brazil, Canada , Japan and the USA.

Source: iso.org