The FDA has been deciding on how to work the ISO 13465-2016 into the QSR for many years. The covid situation has put this process on hold, but it is appears it is now back on the agenda.
These changes are supposed to make the FDA QSR more in line with the ISO standard. The new FDA quality regulations will be called, QMSR (Quality Management System Regulations). This announcement was published today (see below)
Today, the U.S. Food and Drug Administration (FDA) published a proposed rule, Medical Devices; Quality System Regulation Amendments. Through this rulemaking, the 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.
While the current QS regulation provides sufficient and effective requirements for the establishment and maintenance of a quality management system, regulatory expectations for a quality management system have evolved since the regulation was implemented over 20 years ago. The FDA seeks to explicitly require current internationally recognized regulatory requirements for Quality Management System (QMS) for devices subject to the FDA’s jurisdiction.
This action, if finalized, would harmonize quality management system requirements for devices with requirements used by many other regulatory authorities around the world.
The proposed rule will be open for public comments for 90 days at www.Regulations.gov under docket number (FDA-2021-N-0507)
On March 2, 2022, the FDA will hold a public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee. The committee meeting will provide information about the proposed rule and offer an opportunity to discuss the requirements and potential impacts of this proposed amendment to the agency’s regulations.
If your company is ISO13465 certified, you will find meeting these new QMSR requirements easier to apply. If your are practicing FDA QSR only, you will be in for a new set of rules you may find difficult to understand.
mdi’s team is reviewing these proposed changes and we will be updating you in the near future.
mdi will continue to monitor the FDA’s decision on amending current current good manufacturing practice requirements of the Quality System (QS) regulation (21 CFR Part 820). For more information on this FDA policy please contact mdi at: firstname.lastname@example.org and ref: Quality System (QS) regulation (21 CFR Part 820).