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General Considerations for Animal Studies Intended to Evaluate Medical Devices Guidance for Industry and Food and Drug Administration Staff March 2023

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-3419.

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