"Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated
how best to ensure that consumers have access, as quickly as possible, to new and improved
medical devices and, at the same time, prevent devices that are not safe and effective from
entering or remaining on the market. Medical device regulation is complex, in part, because of the
wide variety of items that are categorized as medical devices; examples range from a simple
tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect
their cost, quality, and availability in the health care system..."
Medical devices regulation
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