On February 23, 2022 the FDA published a proposed regulation, requesting public comment, to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) to incorporate the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.
Public comment on this proposed regulation will be accepted through May 24, 2022.
Read more about the proposed regulation in the Federal Register.