Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. 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 implanted mechanical/hydraulic urinary continence device, a generic type of medical device intended for the treatment of urinary incontinence.  This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification*; D005762:Gastroenterology / Q000295:instrumentation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014549:Urinary Incontinence / Q000628:therapy*; D014572:Urology / Q000295:instrumentation