The Food and Drug Administration has issued a final rule to require the filing of a premarket approval application or a notice of completion of a product development protocol 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 the FDA will propose to reclassify from class III (premarket approval required) into class II (special controls) the generic type of temporary mandibular condyle prosthesis intended for temporary reconstruction following surgical ablation of malignant and benign tumours.

[See also Pharmaceuticals Newsletter No. 11&12, November & December 1997]

Reference: Federal Register 63(250): 71743-46 (1998).