21 CFR 820 and ISO 13485 harmonization – we have a date

Hamburg, 31.01.2023, Lukas Block

In Order: About one year ago a proposed rule (Link) was issued in the federal register of the USA. With this rule the FDA intends to adapt the Quality System Regulation to harmonize it with the ISO 13485:2016. Until May 2022 comments could be provided. Now we have a date or at least an intended timeline for the final rule. “12/00/2023” is written in the respective field on the Website of the Office of Information and Regulatory Affairs (Link). Thus, it looks like we may anticipate the final rule within this year.”