FDA Issues Final Guidance on Animal Studies for Dental Bone Grafting Devices
The United States Food and Drug Administration has finalized guidance clarifying when animal studies are needed for 510(k) submissions of dental bone grafting devices. The recommendations emphasize real-world testing environments, risk mitigation, and reducing reliance on animal testing when possible.
The United States Food and Drug Administration (FDA) has issued final guidance for manufacturers of dental bone grafting devices, focusing on the use of animal studies to meet regulatory requirements. Dental bone grafting materials are used to augment and reconstruct bone in the jaw and face, and the agency emphasized that animal studies are often necessary to evaluate safety and performance in ways that cannot be assessed through bench or clinical testing alone.
The guidance advises that animal studies should reflect real-world surgical conditions and consider details that may appear on product labeling, such as instructions for use and auxiliary materials. While the recommendations largely mirror the draft issued in March 2024, the FDA reinforced the importance of tailoring study design to the device’s mechanism of action and potential risks. Importantly, the agency continues to encourage the use of alternatives under the “3Rs” framework — replace, reduce, and refine animal use — while promoting early consultation through its Q-Submission Program. Click here to read more.
