Oversight Overhaul: Eliminating the Premarket Review of Medical Devices and Implementing a Provider-Centered Postmarket Surveillance Strategy

摘要

Several times a month, debilitating migraines force a young college student to miss class, study time and social events. During migraine attacks, she experiences extremely painful headaches, nausea and sensitivity to light and sound. Despite using prescription medications and over-the-counter painkillers, she finds little relief. While researching alternative treatment options, her doctor discovers a new medical device that uses Transcranial Magnetic Stimulation (TMS) technology to treat migraines. The TMS device appears promising, but there is one major problem-the U.S. Food and Drug Administration (FDA) has not yet cleared the device for entrance into the U.S. market.