The U.S. FDA proposed an amendment to device current good manufacturing practice requirements of the Quality System Regulation to align more closely with the international consensus standard for devices.
The FDA proposed converging with the quality management system requirements used by other regulatory authorities from other jurisdictions, like those from other countries, for example.
The Food and Drug Administration (FDA) published a proposed rule in the Federal Register “proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with… the 2016 edition of ISO 13485.”
While mainly procedural, the goal of the rule is to make compliance easier and more efficient, and to avoid creating inconsistencies with other applicable FDA requirements. Some industry participants who manufacture medical devices have already expressed concern with the proposed effective date of one year after the rule is finalized.
Comments on the proposed rule, which was introduced in February, are due May 24, 2022.
Read the full article at The National Law Review.
