Medical devices; classification of temporomandibular joint implants--FDA. Final rule

The Food and Drug Administration (FDA) is classifying four temporomandibular joint (TMJ) implants, the total temporomandibular joint prosthesis, the glenoid fossa prosthesis, the mandibular condyle prosthesis, and the interarticular disc prosthesis (interpositional implant), into class III (premarket approval). These actions are being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) and the Safe Medical Devices Act of 1990 (the SMDA).