Since 1976, the Food and Drug Administration (FDA) has been increasingly involved in the regulation of medical devices, much as it has been involved for decades in the regulation of drugs. For the ophthalmic profession and industry, this regulatory role of the FDA that requires documentation of safety and effectiveness has often appeared as both burdensome and detrimental to new developments.
The most visible and immediate effect of FDA regulation has been on the development of new devices designed to improve the practice of ophthalmology but which at the same time present major potential risks. Delays in the availability of new devices for general use are understandably perceived as a negative effect of the FDA's involvement. Furthermore, during the course of investigation of a new device, investigators are required by the FDA to establish both its safety and effectiveness. The need to collect and report extensive data to the manufacturer