On July 21, 2016, the FDA will hold a webinar for industry to review the Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” final guidance document. The recommendations in this final guidance clarify and update how medical device developers may use ISO 10993-1 standard in their premarket submission to determine the potential for an unacceptable adverse biological response resulting from contact of a medical device with the body.
Webinar Details: Registration is not necessary
Date: July 21, 2016
Time: 1:00 -2:30 PM, Eastern Time.
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.
NOTE: You must dial-in to hear the presentation and ask questions:
Dial: 888-664-9861, passcode: 8730789
International Callers Dial: 1-630-395-0354
To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PW8727057&p=8730789&t=c
Conference Number: PW8727057