Zdrowie i gospodarka · 14/10/2015

General Considerations for Animal Studies for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "General Considerations for Animal Studies for Medical Devices." FDA has developed this guidance document to assist industry in designing evaluation strategies for, and reporting the results of, animal studies for medical devices. The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to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 (IDE) application) or to demonstrate device safety in support of a marketing application, while incorporating modern animal care and use strategies. This draft guidance is not final nor is it in effect at this time.