Food and Drug Administration regulation of spinal implant fixation devices.

The role of the Food and Drug Administration in regulating medical devices generally is not well understood by physicians. The practice of medicine does not fall under Food and Drug Administrations's regulatory purview. Nevertheless, the Food and Drug Administration and its regulation of medical devices can influence physicians' activities. This article provides an overview of the scope of the Food and Drug Administration's authority and the agency's regulatory framework, with particular focus on orthopaedic medical devices as related to spinal implant devices. During the past 10 years, a regulatory dilemma has arisen surrounding the use of bone screws in the pedicles of the spine. Except for recent clearances for a limited treatment indication, the Food and Drug Administration has not cleared these devices to be labeled for pedicle screw fixation and, therefore, has restricted industry supported educational activities pertaining to this type of treatment. In spite of the Food and Drug Administration's regulatory position, physicians have chosen to use pedicle screw fixation in treating patients who have a variety of spinal disorders. This use is now considered an accepted (state of the art) medical practice by many physicians for certain spinal conditions. This article explores this specific Food and Drug Administration regulatory issue, its impact on physicians and manufacturers (especially as it pertains to medical education), and recent actions taken to resolve it.