FDA finalises animal study guidance for bone graft devices

Iveta Ramonaite, Dental Tribune International

Tue. 23. September 2025

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SILVER SPRING, Md., US: The US Food and Drug Administration (FDA) has finalised guidance on animal studies for dental bone grafting material devices, aiming to reduce reliance on animal testing in premarket submissions. Published in August 2025, the document updates earlier guidance from 2005 and is intended to reflect current review practices, promote consistency and streamline the evaluation of submissions.

The agency first issued a draft version of the document in March 2024. The final guidance document sets out detailed recommendations for animal studies that may be used to demonstrate compliance with special controls applicable to dental bone grafting devices. It outlines considerations such as selecting anatomical sites consistent with intended intra-oral use or using worst-case defect models.

Talking to Dental Tribune International, the FDA emphasised that the document serves as a resource for manufacturers developing new or novel biomaterials, helping them evaluate safety and performance for marketing submissions. For companies that still conduct animal testing, the recommendations are designed to ensure that adequate in vivo data is provided. At the same time, the FDA encourages sponsors to consult with the agency if they wish to use validated, non-animal alternatives.

“The FDA believes that the detailed animal study recommendations provided in this guidance may help assist manufacturers in providing adequate animal study data, when an animal study is conducted to support a 510(k) submission for dental bone grafting material devices,” an FDA spokesperson told Dental Tribune International.

A central focus of the document is support for the 3Rs: replace, reduce and refine animal use. The FDA noted that the document may help lower the number of animals needed by combining safety and performance studies with biocompatibility testing in a single design.

Ensuring safety, performance and ethical testing standards

Bone grafting has become increasingly common in dentistry owing to advances in regenerative medicine, development of new biomaterials and rising demand for bone restoration. According to a 2021 study, up to half of all implant procedures involve a graft, amounting to approximately 2.2 million procedures performed worldwide each year. Although autografts remain the gold standard, xenografts sourced from bovine and porcine bone are widely used.

By finalising this guidance document, the FDA seeks to provide manufacturers with greater clarity, support innovation in dental biomaterials and encourage the adoption of testing approaches that ensure safety and performance while limiting animal use.

Editorial note:

References

Zhao R, Yang R, Cooper PR, Khurshid Z, Shavandi A, Ratnayake J. Bone grafts and substitutes in dentistry: a review of current trends and developments. Molecules. 2021 May 18; 26(10):3007. doi: 10.3390/molecules26103007
Meenu G, George VT, Manohar R, Thomas NG. Applications of xenografts in periodontal regeneration. IP Int J Periodontol Implantol. 2021;6(4):184–91. doi: 10.18231/j.ijpi.2021.032