J Am Acad Orthop Sur
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J Am Acad Orthop Sur · May 2008
ReviewThe FDA process for the evaluation and approval of orthopaedic devices.
The US Food and Drug Administration (FDA) is a scientific, regulatory, and public health agency whose authority includes overseeing the marketing of products relevant to medical practice. Devices are classified based on the extent of oversight needed to ensure public safety. Divisions within the FDA provide specific expertise regarding drugs, devices, biologic products, and combinations thereof. ⋯ Expert panels advise the agency on issues related to product safety and efficacy, and clinical studies may be required to provide data based on these parameters. Clinical data are monitored postapproval for potential adverse events not evident in earlier trials. Orthopaedic surgeons are involved in all aspects of the FDA as employees, consultants, product advocates, participants in clinical trials and advisory panels, and experts involved in the appropriate reporting of adverse events.
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Carpal tunnel syndrome is considered the most common of the chronic compressive neuropathies. Its cause is generally unknown. ⋯ Many rare and unusual causes have been described, including chronic conditions that may be associated with acute carpal tunnel syndrome, such as rheumatologic disorders and anomalous anatomy. In contrast to the more common chronic idiopathic form, the acute form of carpal tunnel syndrome requires urgent surgical intervention to avoid or diminish serious sequelae.