The FDA today published a long-awaited proposal to overhaul U.S. medical device quality regulation to better align with regulations worldwide.
The proposed rule, Medical Devices; Quality System Regulation Amendments, incorporates ISO 13485:2016, the international consensus standard for medical device manufacturers. The reduced complexity in the regulatory process could provide FDA cost-savings in the $439 million to $533 million range over the next 10 years, according to the proposal’s executive summary.
According to the agency, regulatory expectations for a quality management system have evolved since the FDA’s present regulation was implemented over 20 years ago.
The FDA said in its bulletin that it wants to harmonize quality management system requirements for devices with requirements used by many other regulatory authorities worldwide.
The FDA went on to explain in the proposal’s executive summary: “These additions will ensure that the incorporation by reference of ISO 13485 does not create inconsistencies with other applicable FDA requirements. … The rule, if finalized, would converge QS regulation with the QMS requirements of ISO 13485, while continuing to provide the same level of assurance of safety and effectiveness under the FD&C Act and its implementing regulations.”
The proposed changes also clarify the device QMS requirements for combination products.