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Announcing 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” and FDA Webinar on the Final Guidance on July 21, 2016

Today we issued the final guidance document Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.”

This final guidance allows manufacturers to use the ISO 10993-1 standard when assessing the potential biological response of the medical devices and materials that come into direct or indirect contact with the human body. Specifically, 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.”

Additionally, this guidance highlights the concept that a biocompatibility assessment should begin with a risk-based approach instead of immediately considering new biocompatibility testing.  If the risk assessment indicates that biocompatibility testing is warranted, new test-specific recommendations are included in this guidance to address common deficiencies identified in premarket submissions.  Implementation of the recommendations in this guidance will occur on September 14, 2016.

On July 21, 2016, the FDA will hold a webinar for industry to discuss the recommendations in 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. We welcome your questions about this final guidance, so please plan to participate. No registration is required.

Webinar Details:

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 Following the webinar, written transcript, audio recording and slides will be available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041301-796-7100 or at dice@fda.hhs.gov.

Thank you,
Food and Drug Administration
Center for Devices and Radiological Health