Zdrowie i gospodarka · 26/09/2000

FDA Issues Final Rule Requiring Premarket Approval for Implanted Urinary Continence Devices

The US Food and Drug Administration (FDA) is mandating that manufacturers submit a premarket approval application or a product development protocol completion notice for implanted mechanical/hydraulic urinary continence devices, used to treat urinary incontinence, in accordance with the Federal Food, Drug, and Cosmetic Act and related amendments.