The American journal of orthopedics
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The Food and Drug Administration (FDA) does more than regulate food and drug products. Through its medical device evaluation process, FDA affects every orthopedic surgeon's practice and every orthopedic patient every day. FDA regulations affect the development of each orthopedic device in some way, from the product's inception to its senescence, but the regulatory process and what the FDA's stamp of approval means are not part of the curriculum in medical school or residency. ⋯ How different types of devices get to the patient are reviewed, and the basics of the regulatory process are explained in this paper. Common myths are set straight, and FDA's concerns with "off-label" use are discussed. The role of the orthopedic surgeon in the regulatory process is also introduced.
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This comprehensive review article encompasses a broad variety of topics within the spinal literature and includes an update on the latest technology and techniques for the spine.