Repair of bone and joint tissue to restore normal function is a unique endeavor that requires recreating tissue structure and the integrated healing of both organic and inorganic tissue components. Session 5 (Structural approaches to bone and joint repair) at the 36th annual Society of Toxicologic Pathology Annual Symposium included 2 talks covering methods, models, and regulatory considerations used to evaluate novel approaches for repairing bones and joints. Lyn Wancket provided a general overview of medical devices, with an emphasis on preclinical and clinical evaluations of bone and joint devices. Karen Manhart outlined regulatory review of medical devices by the Food and Drug Administration. This summary includes highlights from both talks.
Keywords: animal models; medical devices; musculoskeletal system; regulatory affairs; safety assessment.