On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No. FDA-2021-N-0507). The proposed rule seeks to amend the device good manufacturing practice (GMP) requirements of the Quality System Regulation (21 CFR Part 820) to incorporate by reference the International Organization for Standardization (ISO) - ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes, Third Edition 2016-03-01 (“ISO 13485”). The goal of the proposed rule is to streamline and harmonize FDA’s Quality System Regulation (QSR) with the globally recognized Quality Management System requirements issued in 2016 by ISO, an independent, nongovernmental international organization. ISO 13485 has been implemented throughout the global medical device industry and used by many regulatory authorities around the world as their standard for a Quality Management System (QMS).