ABSTRACT
During the process of classifying devices (see Appendix F) the Food and Drug Administration (FDA) may establish labeling requirements for specific device categories. These requirements are usually broader in scope than the device-specific requirements established during the 510(k)/premarket approval application (PMA) review process described in Chapter 24. Occasionally, during the review of a product application, the FDA will identify a labeling issue of sufficient importance to make a general rule requiring specific wording in the labeling. For example, the FDA has determined that orthopedic bone-screw labeling must bear the warning: “WARNING: This device is not approved for screw attachment or fixations to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine” (Spinal System p. 10). These requirements appear in guidance documents or other communications targeted at the affected manufacturers. Eventually, some of these requirements are incorporated directly into the Code of Federal Regulations (CFR). This chapter summarizes these special labeling requirements.
