Final Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
The U.S. Food and Drug Administration (FDA) is issuing this final guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices.
The FDA developed this guidance document 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.
Animal studies are conducted to support medical device premarket submissions, when warranted. The in vivo setting of an animal study generally provides an initial assessment of how a medical device interacts with biological systems, including physiological, pathological, and toxicological effects of the device, and how the biological system may affect the device.
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.
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