title: Cochlear implants: overview of safety and effectiveness. The FDA evaluation.
abstract: Under authority of the Federal Food, Drug, and Cosmetic Act, as amended in 1976, the Food and Drug Administration requires manufactures of new medical devices, such as cochlear implants, to demonstrate the safety and effectiveness of their devices before marketing them. This article describes the FDA review process and the kinds of data the FDA is looking for in premarket approval applications for cochlear implants. It also discusses some of the issues surrounding the premarket approval applications which have already been approved.
mesh_terms: D002986:Clinical Trials as Topic; D003054:Cochlear Implants / Q000592:standards; D004869:Equipment Safety; D005500:Follow-Up Studies; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design; D014481:United States; D014486:United States Food and Drug Administration