FDA Issues Final Guidance and Presents Webinar on Biological Evaluation of Medical Devices

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FDA Issues Final Guidance and Presents Webinar on Biological Evaluation of Medical Devices

Catherine Sprankle, NICEATM

The U.S. Food and Drug Administration (FDA) has issued a final guidance document on the use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process.” FDA developed the guidance document to assist industry in preparing applications and notifications on medical devices so that the devices are appropriately evaluated for the potential for adverse reactions.

FDA will present a webinar on the new guidance on July 21 at 1:00 p.m. Eastern Daylight Time. The webinar is open to the public and there is no charge to view.

Catherine Sprankle
Catherine Sprankle
Communications Specialist for NICEATM