| Abstrakt: |
This article focuses on cardiac pacing devices. When the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act became a law in 1976, the U.S. Food and Drug Administration (FDA) became part of the process by which new pacing systems are clinically investigated and marketed. It is no longer acceptable for the manufacturer to satisfy only the concerns of the clinician, he must also be able to provide clear, objective data from multicenter studies to satisfy the FDA's concerns. Under the best of circumstances, when manufacturers and clinical researchers do their jobs well, the FDA may exert little influence and the FDA's regulation may result in only slight delays in the marketing of new devices. |
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