FDA Releases An Updated Version of ISO-10993

The FDA has released an updated version of ISO-10993. It has 70 pages that are chocked full of info that will help us evaluate biocompatibility for medical devices!!! Don’t worry, the Endpoint Evaluation Matrix is still there!!

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”

If you have any questions about the new guidance or need help with your biocompatibility evaluation, let O’Connell & Myers help you navigate the new guidance.