FDA Proposes Major Changes to Medical Device Quality Regulation

The U.S. FDA published a proposal on why U.S. medical device quality regulations should be overhauled to be more akin to global regulations.

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.

Read the full story at Medical Design and Outsourcing.