US Device Biocompatibility Guidance Adds Nanotech, Absorbability Test Tips

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.