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FDA PROPOSES MAJOR CHANGES TO MEDICAL DEVICE QUALITY REGULATION

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.