FDA Set to Propose Adoption of ISO 13485 for Quality Systems

In an effort to harmonize its medical device quality management system regulations with globally-accepted standards, the U.S. Food and Drug Administration (FDA) is reportedly set to propose the adoption of ISO 13485:2016 as a replacement for its current Quality System Regulations (QSRs).

According to reports by The Emergo Group, the British Standards Institute (BSI), the Regulatory Affairs Professional Society (RAPS) and others, the proposed change is part of the federal government’s Spring 2018 “Unified Agenda of Federal Regulatory and Deregulatory Actions,” and reflects efforts by the FDA to make it easier and more efficient for medical device manufacturers to sell their products outside of the U.S. while continuing to maintain high quality standards.

The move would also complement the FDA’s involvement in the Medical Device Single Audit Program (MDSAP), which was established to facilitate the acceptance of audits of device manufacturer’s quality management programs by other MDSAP-participating national regulators.

Read the report by The Emergo Group on the proposed adoption of ISO 13485.

Read the BSI report on the proposed adoption of ISO 13485.

Read the RAPS report on the proposed adoption of ISO 13485.

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