Obstetric and gynecology devices; effective date of requirement for premarket approval for glans sheath devices. 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 product development protocol (PDP) for glans sheath medical devices. The agency has previously published its 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.
D003273:Contraceptive Devices / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D004869:Equipment Safety; D006176:Gynecology / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D009774:Obstetrics / Q000145:classification / Q000295:instrumentation*; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration