Device Safety

Medical devices are essential in the diagnosis and treatment of otolaryngologic disease. The US Food and Drug Administration (FDA) is tasked with assuring the safety and effectiveness of these devices. Otolaryngologists, in turn, are often responsible for helping patients understand risks, benefits, and alternatives when deciding whether to rely on devices in their care. To best counsel patients, otolaryngologists should be aware of the strengths and limitations of device regulation by the FDA. This article reviews the FDA regulatory framework for medical devices, premarket evidentiary standards for marketing devices, and postmarket methods of safety surveillance.