The US FDA is integrating ISO 13485:2016 into its medical device regulations (QMSR) by reference, with a compliance deadline of February 2, 2026. This change aligns US standards with global norms, requiring companies to update quality management systems, conduct gap analyses, and train staff for effective implementation.

The US FDA is incorporating ISO 13485:2016 into its Quality Management System Regulation (QMSR) with a compliance deadline of February 2, 2026. This change aims to align US medical device regulations with international standards, emphasizing risk management, process validation, and regulatory compliance. Medical device manufacturers must prepare for this transition to ensure compliance and enhance global market access.

SO 13485 is an internationally recognized standard that outlines the requirements for a quality management system specific to the medical devices industry. It ensures that organizations consistently design, develop, produce, and deliver medical devices that meet both customer and regulatory requirements. Essentially, ISO 13485 provides a framework for managing the quality of medical devices throughout their lifecycle.

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FDA to adopt ISO 13485 in Feb 2026, aligning U.S. medical device regulations with global standards for improved quality and market access.