- July 20, 2016
08:00 PM - 08:00 PM EDT
On July 21, 2016, the FDA held 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."
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@example.com, 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health