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US Device Biocompatibility Guidance Adds Nanotech, Absorbability Test Tips

This article was originally published in SRA

Executive Summary

A long-awaited final guidance from the US Food and Drug Administration covering biocompatibility testing of medical devices adds several new sections compared with a draft version issued in April 2013, including recommendations for taking a risk-based approach to biological testing of materials, chemical testing, and test-article preparation for devices with nanotech and submicron components1-3.