The Food and Drug Administration and the regulation of clinical trials for endosseous implants

The Office of Device Evaluation (ODE), within the Center for Devices and Radiological Health of the Food and Drug Administration is the primary component responsible for the premarket review of medical devices. Dental devices are reviewed by the Dental Devices Branch within ODE. Premarket submissions to FDA for dental endosseous implants should include complete characterization of the device and often may necessitate the inclusion of mechanical and other bench testing and clinical data. FDA guidance documents are available which outline the information that should be included in the submissions. The guidance document for premarket approval submissions for dental endosseous implants also provides guidance on clinical trials for dental implants. This guidance document addresses such issues as the number of patients and study sites, length of follow-up, post-implant assessment, and pooling of data. The review of dental endosseous implants involves many challenging issues, including success/failure criteria, new designs and new indicated uses. The Dental Branch continues to gather information to address these issues.