The FDA has declared its intention to harmonize and modernize 21CFR 820, the regulation of the Quality Management System (QMS) related to Medical Devices.


The existing Quality System requirements will be replaced with the specifications of the harmonized International Standard EN ISO 13485:2016.

This revision aims to reduce compliance and documentation retention obligations for device manufacturers by harmonizing national and international requirements.

Indeed, these changes will align 21CFR 820 with the harmonized ISO 13485:2016: 2016 Standard.

In April 2019 the FDA will publish a first proposal under public consultation through a Notice of Proposed Rulemaking (NPRM).