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Risk Principles and Medical Devices: A Postmarket Perspective

In collaboration with the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the Association for the Advancement of Medical Instrumentation (AAMI) convened an informal working group in the fall of 2014, whose purpose was to develop a shared understanding of risk principles that would guide both the medical device industry and CDRH in assessing and managing risk in the postmarket setting. This white paper and the risk principles and risk factors and it identifies are focused on postmarket quality and safety issues and related activities by industry and CDRH. Representatives from industry and CDRH participated in the project, and this white paper is a synthesis of their work.

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