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FDA Biocompatibility Guidance Adds Nanotech, Absorbability Test Tips

This article was originally published in The Gray Sheet

Executive Summary

A June 15 FDA final guidance on biological evaluation of devices adds new sections on biocompatibility testing compared to the 2013 draft version, including a risk-based approach to biocompatibility testing, as well as test article preparation recommendations for devices with submicron/nanotech components, in situ polymerizing or absorbable materials, and tips for chemical testing.

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