Devices

Guide on Animal Studies for Devices

FDA is making available a final guidance entitled “General Considerations for Animal Studies Intended to Evaluate Medical Devices.” The document is intended to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies that are conducted to assess device safety and to support premarket submissions.

“These animal studies typically provide initial evidence of device safety, which may include device performance and handling, and the biological effects of the device when used in a living system,” the guidance says. “The recommendations in this guidance reflect current review practices and are intended to promote consistency and facilitate efficient review of medical device submissions that include animal study data.”

The guidance acknowledges that an animal study can have multiple purposes beyond a safety assessment. “For example,” it says, “a secondary objective for conducting an animal study can be to evaluate the effectiveness of the device or to demonstrate proof of concept and principle of operation. Manufacturers could also conduct an animal study to help meet design verification and validation requirements.”

Additionally, it provides recommendations on the credentials for personnel conducting such studies, and study planning and conduct processes (animal model, study monitoring, and study evaluation). It also provides recommendations on testing facility selection, animal housing, records and reports, and how to prepare an animal study report for submission to FDA.

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