In December 2023, the FDA is carrying out an update of 21 CFR 820 (Quality System Regulation) to align it with the specifications of ISO 13485:2016.
The aim of this revision is to promote more advanced risk management principles while at the same time reducing the regulatory burden for manufacturers and importers of medical devices by harmonising national and international requirements.
This development is positive above all for medical device manufacturers from the EU that have already established a quality management system in accordance with ISO 13485.
The FDA provides information on the alignment here:
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202210&RIN=0910-AH99