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. This final guidance replaces the Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing.”
We welcome your questions about this final guidance, so please mark your calendars to participate.
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=PW8727057p=8730789t=c
Conference Number: PW8727057
Following the webinar, written transcript, audio recording and slides will be available at Medical Device Webinars and Stakeholder Calls.
NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.
Target Audience: Industry
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health
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