Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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.

Advertisement

Related Content

Nanotech: FDA Seeks Input On Needed Device Tests, Defends Budget Request

Topics

Advertisement
UsernamePublicRestriction

Register