US FDA announces plans to use ISO 13485 for medical devices regulation

The US Food and Drug Administration (FDA), the Federal Agency responsible for regulating the medical devices sector, has announced its plans to use ISO 13485 as the basis for its quality system legislation. The decision marks an important milestone for the FDA and is another step towards the global harmonisation of regulatory requirements in the medical devices sector.

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ISO 13485 is an international standard which defines quality management system (QMS) requirements for manufacturers of medical devices.  The new version, published in 2016, aims to facilitate harmonised QMS requirements for regulatory purposes within the medical devices sector.

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