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

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.

Advertisement
Advertisement
UsernamePublicRestriction

Register

MT040820

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Add a personalized Question to your Analyst

Cancel