May 18, 2018


  • 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.

Global convergence of QMS requirements?

Although similarities exist between FDA QSR and ISO 13485 requirements, US medical device market applicants must ensure compliance specifically to 21 CFR Part 820 in order to register their devices for sale, regardless of whether they have already obtained ISO 13485 certification.

Adoption of the ISO 13485 QMS standard by US regulators would ultimately reduce quality system compliance requirements for manufacturers obtaining marketing authorization in the US as well as other countries already enforcing ISO 13485 requirements.

Manufacturers already compliant to ISO 13485:2016 would thus benefit from easier US market access without having to implement FDA QSR processes. Companies that currently maintain compliance to 21 CFR Part 820 but not ISO 13485:2016, however, would have to undertake transition projects if and when US regulators switch to the ISO QMS framework.

The proposed switch to ISO 13485, coupled with FDA’s involvement in the Medical Device Single Audit Program (MDSAP) for mutual acceptance of QMS audit reports by five participating market regulators, indicate stepped-up efforts by FDA to facilitate more streamlined and globally oriented registration requirements.  

Related US FDA and quality system information from Emergo:


  • Stewart Eisenhart