The US Food and Drug Administration has published a final guidance document titled: ‘General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff’, available from here.
The introduction to the guidance states:
“This guidance document provides the FDA’s recommendations on animal studies intended to evaluate medical devices intended for human use, when a suitable alternative to an animal study is not available. This guidance specifically applies to animal studies intended to assess device safety, which may include performance and handling, in premarket submissions to FDA. This guidance provides recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including but not limited to selecting an appropriate animal model, study monitoring, and study evaluation. This guidance also provides recommendations on testing facility selection, animal housing, records and reports, and how to prepare an animal study report for premarket submissions to FDA. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of medical device submissions.”
This final version replaces the draft guidance issued on 14 October 2015 and also supersedes the device-specific ‘Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices,’ issued on 29 July 2010.