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Medical Devices / Regulatory Affairs

FDA to Consider Mapping of ISO 13485

March 9, 2018

The FDA is moving closer to a decision on whether to add clauses from ISO 13485:2016 to the regulatory requirements for U.S. medical devices.

 “In the spirit of global harmonization of quality management systems, the FDA is considering an evaluation/mapping of the 13485 clauses to the appropriate U.S. regulatory requirements,” an agency official said.

The FDA plans to publish a proposed rule early in 2019 aligning the current Quality System Regulationwith the international standards of ISO 13485:2016.

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