USA – Medical Device QMS Harmonization: US Considers Aligning to ISO 13485

  • US FDA is considering adoption of ISO 13485:2016 quality system requirements for medical device registrants.
  • ISO 13485 would replace FDA Quality System Regulations (QSR) according to proposed rules.
  • FDA alignment to ISO 13485 quality principles would align the US market pathway more closely to other major device markets.

US medical device regulators’ plan to replace components of FDA Quality System Regulations with ISO 13485 requirements will potentially result in making compliance more efficient for manufacturers commercializing in multiple markets.

Included in the Trump Administration’s recently published series of regulatory reform plans, the Harmonizing and Modernizing Regulation of Medical Device Quality Systems proposed rule would replace US medical device Quality System Regulations (QSR) under 21 CFR Part 820 with the ISO 13485:2016 quality management system (QMS) standard. Medical device regulators in regions including the European Union, Japan, Canada and Australia base their quality system requirements on ISO 13485, so the new proposal would align US QMS requirements with those of several other major markets…