Almost a year ago, a proposed rule was published in the federal register of the USA, outlining the FDA's plans to adjust the Quality System Regulation to harmonize it with ISO 13485:2016. The deadline for submitting comments has already expired in May of last year. Now we have a date or at least a planned time horizon for the publication of the final rule. "12/00/2023" is stated on the website of the Office of Information and Regulatory Affairs. So, we can expect the new rule to be released within this year.
