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Guidance on Animal Studies for Medical Devices


Federal Register Notice: FDA is making available a draft guidance entitled General Considerations for Animal Studies for Medical Devices. It has been developed to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. Its intent is to provide a reference of best practices for the approach to, and conduct of, animal studies and the presentation of animal study data intended to demonstrate that the device under study is sufficiently safe for early human experience (e.g., to support an investigational device exemption application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. To download this guidance, click here. To view this notice, click here.