When a medicine or implant is approved for sale by the FDA , it is approved for a set of specific indications (uses). The manufacturer is limited in marketing the medicine or the device for only certain indications that have been reviewed and approved by the FDA. However , physicians and surgeons may use these medicines and implants for other reasons (off-label use) only medical doctors have the necessary knowledge , training and professional judgment to decide when and where medicines and implants are to be used appropriately. Our right to exercise this judgment is bestowed on us by our medicine license. Insurance companies , hospitals , and other healthcare entities do not have a license to practice medicine. The FDA realizes that it is impossible to require separate testing and approval for each possible individual use of a medicine or implant , therefore the government has developed this two-tiered approach to regulation.