FDA DRAFT guidance for animal studies of medical devices…

October 2015

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “General Considerations for Animal Studies for Medical Devices.”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 The intent of this draft guidance is to provide a reference of best practices for the approach to, and conduct of, animal studies, and the presentation of animal study data intended to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 This draft guidance is not final nor is it in effect at this time. Submit either electronic or written comments on the draft guidance by January 12, 2016. Link to the federal register notice below:

http://www.gpo.gov/fdsys/pkg/FR-2015-10-14/pdf/2015-26055.pdf