Opinion ID: 2777754
Heading Depth: 3
Heading Rank: 2

Heading: The FDA's Regulation of Medical Devices

Text: The FDA regulates the labeling and marketing of medical devices pursuant to the Food, Drug, and Cosmetics Act (FDCA). Under section 510(k) of the FDCA, the agency can clear a device that is substantially equivalent in safety and effectiveness to an existing approved device and thereby allow the device to be used for the same intended purposes. The FDA may also grant an investigational device exemption (IDE) to a company to allow it to use a device in a clinical study to test its safety and efficacy. Under FDA regulations, a company is not allowed to market a device for a use for which it has not been approved -- that is, an off-label use. However, the FDA does not prohibit physicians and hospitals from off-label use of medical devices, and a medical device company is allowed to respond to unsolicited requests from physicians for information regarding off-label uses of the company's products. FDA regulations also prohibit a company with an IDE from representing that the device is safe and effective for the purpose for which it is being tested.