FDA Issues Proposal to Amend Medical Device Quality System Regulation
Today, the U.S. Food and Drug Administration (FDA) published a proposed rule, Medical Devices; Quality System Regulation Amendments.
Tue Feb 22 2022
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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.