Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. 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 the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.
D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004867:Equipment Design; D004869:Equipment Safety; D006622:Hip Prosthesis / Q000592:standards*; D006801:Humans; D007883:Legislation, Medical; D009983:Orthopedic Equipment / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration