THE APPROVAL PROCESS FOR MEDICAL DEVICES - CASE OF THE PENILE PROSTHESIS

The penile prosthesis AMS Hydroflex was successfully introduced in 198 5, yet only 5 years later was withdrawn from the market. The approval process of medical devices in the USA and Switzerland is critically an alyzed. While the American Food and Drug Administration (FDA) is respo nsible for approving the marketing of medical devices in the USA no su ch office exists in Switzerland. In Switzerland the physician takes fu ll responsibility when using a device. It is, however, intended to int roduce similar to the USA three regulatory control categories dependin g upon the degree of regulation necessary to assure safety and effecti veness of each device.