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# Guide on Animal Studies for Devices
- URL: https://www.fdaweb.com/guide-on-animal-studies-for-devices-2/
- Published: 2023-03-28T12:00:00.000Z
- Updated: 2026-09-14T18:22:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154083

*Federal Register* notice: 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. The animal studies are intended to provide initial evidence of device safety, which may include device performance and handling, and the biological effects when used in a living system. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-03-28/pdf/2023-06254.pdf?ref=fdaweb.com).