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ICCVAM Biennial Report 2018-2019

ICCVAM Biennial Report 2018-2019
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Medical Device Development Tools Qualification Program

The FDA Center for Devices and Radiological Health is continuing to expand acceptance of alternative information and non-animal testing to support biocompatibility evaluations of medical devices. The Center’s guidance on Qualification of Medical Device Development Tools explains how new tools can be developed and qualified for a specific context of use, so that qualified tools can be used to support regulatory submissions to the Center. The policy outlined in the guidance is applicable to in vitro models to replace animal testing where appropriate. Slides, an audio presentation, and a transcript of a webinar presented to answer questions on the guidance can be found on the FDA website. To date, biocompatibility or toxicology tools have not yet been qualified under the Center’s Medical Device Development Tool program. Once qualified, these tools will be published in the Medical Devices section of the FDA website.

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