FDA medical device approval: things you didn't learn in medical school or residency

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. Each device follows a specific pathway from manufacture to physician use and patient care depending on the assessment of risk associated with the device or classes of devices. The evaluation of safety and effectiveness involves a complex process of biomechanical, engineering, preclinical, laboratory, clinical, and epidemiological assessment. 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.