FDA Issues Final Guidance on Animal Studies to Evaluate Medical Devices

On March 28, the FDA issued a final guidance, General Considerations for Animal Studies Intended to Evaluate Medical Devices, to assist medical device sponsors, testing facilities, and others involved in designing, conducting, and reporting the results of animal studies intended to assess the safety of medical devices to support premarket submissions.

The 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. Per the FDA’s announcement, this guidance specifically applies to animal studies intended to assess device safety, which may include performance and handling, in premarket submissions to FDA.

It includes recommendations for various elements of animal studies, including the credentials for personnel conducting an animal study, and the study planning and conduct process, including selecting an appropriate animal model, study monitoring, and study evaluation.

General considerations when determining whether an animal safety study should be conducted to support a premarket submission include:

Download the final guidance document here.

 

 

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