US FDA guidance on the use of ISO 10993-1 for the biological evaluation of medical devices: the top

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.

Click here for the full article on Global Regulatory Press.

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