FDA Issues Proposal to Amend Medical Device Quality System Regulations

On 23 February 2022 the FDA issued an amendment proposal for medical device regulation. Comments on the proposed rule may be submitted until 24 May 2022. Comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 are accepted until 25 March 2022.

FDA is proposing to amend the device current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820) primarily to incorporate the international consensus standard for medical device manufacturers set by the International Organization for Standardization (ISO)- ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.