FDA has issued a final guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”.
The document, issued on June 16th, can be accessed through the following link:
There will also be a webinar on the final guidance on July 21, 2016. It will take place from 1:00 -2:30 PM, Eastern Time. For more information use the following link: