The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book Memorandum #G95-1, Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’, dated 1 May 1995. This document persisted unchanged for nearly two decades, even though practices and opinions within the FDA slowly changed. In June 2016, the FDA published the final version of a new guidance document entitled, Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’. The new guidance focuses on the possible biological and toxicological risks presented by medical devices, and outlines testing approaches to address these risks when bringing a medical device to market. This article identifies the top 10 changes to biocompatibility evaluation introduced by the new guidance document and looks at their impact on medical device manufacturers.
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