title: [Approval process of "medical devices" exemplified by the penile prosthesis].
abstract: The penile prosthesis AMS Hydroflex was successfully introduced in 1985, yet only 5 years later was withdrawn from the market. The approval process of medical devices in the USA and Switzerland is critically analyzed. While the American Food and Drug Administration (FDA) is responsible for approving the marketing of medical devices in the USA no such office exists in Switzerland. In Switzerland the physician takes full responsibility when using a device. It is, however, intended to introduce similar to the USA three regulatory control categories depending upon the degree of regulation necessary to assure safety and effectiveness of each device.
authors.affiliation: Departement Chirurgie, Kantonsspital Basel.
authors.forename: T C
authors.initials: TC
authors.lastname: Gasser
authors.forename: M
authors.initials: M
authors.lastname: Riehmann
authors.forename: R C
authors.initials: RC
authors.lastname: Bruskewitz
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004869:Equipment Safety; D006801:Humans; D008297:Male; D008875:Middle Aged; D015917:Penile Prosthesis; D012189:Retrospective Studies; D013557:Switzerland; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
vernacular_title: Zulassungspraxis von "Medical Devices" am Beispiel der Penisprothese.