FDA finalizes guidance on using animal studies to develop dental bone grafting devices
The US Food and Drug Administration (FDA) has finalized guidance for sponsors of dental bone grafting devices regarding using animal studies to meet special controls requirements. The guidance is meant to augment and, in some circumstances, supersede previous related guidance.Dental bone grafting devices are materials used to fill, augment, and reconstruct the area around a patient’s jaw and face. According to FDA, sponsors typically conduct animal studies to prove their safety and effectiveness.
FDA published a draft version of the guidance in March 2024 that generally recommended that sponsors include data from animal studies for 510(k) submissions for bone grafting material devices to address the safety and performance in vivo, independent of how the predicate device has been shown to perform, and details why such studies are necessary in the guidance. The final guidance includes very few changes from the draft version (RELATED: FDA proposes animal study requirements for dental bone grafts, Regulatory Focus, 29 March 2024).
FDA echoed that animal studies should be conducted to evaluate aspects of dental bone grafting materials that cannot be evaluated through bench tests or other clinical studies. The agency also repeated that the design and endpoints in the studies should be based on the device's mechanism of action and that they should mitigate potential risks.
In the final guidance, FDA also added that animal studies should be conducted in testing environments that simulate the real-world clinical setting in which the dental bone grafting material is intended to be used. The agency noted that such testing should also consider details that may go into the proposed label, such as instructions for use, surgical procedure, and use of any auxiliary support materials.
FDA again noted that sponsors should try to replace, reduce, and/or refine animal testing when feasible, or as the agency calls it, the “3Rs.” If sponsors have methods that they would like to use that don’t require animal testing and that they think would be suitable and feasible, the agency recommended that they discuss the methods with regulators early on, using its Q-Submission Program.
Final guidance
