ABSTRACT
Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. Reports suggest that European patients have access to some high-risk medical devices, such as coronary stents and replacement joints, earlier than American patients. The Medical Device Amendments of 1976 gave the FDA primary authority to regulate medical devices and required the FDA to obtain “reasonable assurance of safety and effectiveness” before marketing. In 2004, the guidelines published by the European Commission urged manufacturers to include both general and device-specific follow-up as part of their quality-assurance programs. Central coordination in the United States allows postmarket phenomena in one generation of devices to inform later applications and study designs.
