The US Food and Drug Administration (FDA) on Thursday issued draft guidance for sponsors of dental bone grafting devices that offers advice on using animal studies to meet special controls requirements for such devices. The agency said the guidance is meant to augment and, in some circumstances, supersede previous related guidance.
FDA explains that dental bone grafting devices are materials used to fill, augment, and reconstruct the area around a patient’s jaw and face, and notes that that it typically requires sponsors to conduct animal studies to prove they are safe and effective.
FDA lays out its special controls requirements for the devices in a separate guidance entitled, Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices. In some situations, the agency said the draft guidance would supersede requirements in the dental bone grafting guidance when finalized. The agency also said the draft guidance would supplement – but not supersede – its guidance entitled, General Considerations for Animal Studies Intended to Evaluate Medical Devices…
