Implantable middle ear hearing devices: Food and Drug Administration review process.
This article presents an overview of the role of the Food and Drug Administration in reviewing new devices and then explains this process in some detail as it applies to implantable middle ear hearing devices. The role of the Food and Drug Administration is to protect the patient and physician by reviewing devices for safety and effectiveness before they are made available for general use.
Jaffee
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Ear, Nose, and Throat Devices Branch, United States Food and Drug Administration; and Drug Administration, Center for Devices and Radiological Health, Rockville, Maryland, USA.
D018795:Device Approval; D004432:Ear, Middle / Q000601:surgery*; D006310:Hearing Aids; D006801:Humans; D019736:Prostheses and Implants; D014481:United States; D014486:United States Food and Drug Administration