United States of America. The Food and Drug Administration has proposed to require a premarket approval application or a notice of completion of a product development protocol for the total temporomandibular joint (TMJ) prosthesis, the glenoid fossa prosthesis, the mandibular condyle prosthesis and the interarticular disc prosthesis (interpositional implant).
The agency is also summarizing its proposed findings regarding the degree of risk of illness or injury intended to be eliminated or reduced by requiring the devices to meet the statute’s requirements as well as the benefits to the public from the use of the devices. Additionally, the agency is providing the opportunity for a reclassification of the devices based on new information.
[See also Pharmaceuticals Newsletter No. 2, February 1995]
Reference: Federal Register 62(137): 38231-37 (1997).