Dental devices; effective date of requirement for premarket approval; temporomandibular joint prostheses--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for certain devices, namely, the total temporomandibular joint (TMJ) prosthesis, the glenoid fossa prosthesis, the mandibular condyle prosthesis (for permanent reconstruction), and the interarticular disc prosthesis. At a later date, FDA will propose reclassifying from class III into class II the generic type of temporary mandibular condyle prosthesis intended for temporary reconstruction following surgical ablation of malignant and benign tumors. This action establishing the effective date of the premarket approval requirement for certain devices is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the FDA Modernization Act of 1997 (FDAMA).
D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007595:Joint Prosthesis / Q000145:classification; D013705:Temporomandibular Joint Disorders / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration