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FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan to harmonize its current good manufacturing practice requirements applicable to medical device quality systems with internationally recognized regulations and standards.

Published in the Federal Register, the FDA’s proposed rule would replace the agency’s current quality management systems requirements with those detailed in ISO 13485, “Medical devices-Quality management systems-Requirements for regulatory purposes.” If finalized, the change would harmonize quality management systems requirements for FDA-regulated devices with the requirements in force in other jurisdictions around the world.

Read the FDA’s proposed amendment to the regulation of quality systems for medical devices as published in the Federal Register.

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Comments on the proposed changes must be submitted to the FDA by not later than May 24th and can be filed electronically at www.regulations.gov (reference docket number FDA-2021-N-0507).

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