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ICCVAM Biennial Report 2018-2019

Biennial Progress Report 2018-2019 Interagency Coordinating Committee on the Validation of Alternative Methods
https://ntp.niehs.nih.gov/go/884534

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. 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.

"Guidance on Nonclinical Development ..." - previous article
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