Understanding physician responsibilities and limitations for drug and device off-label use.
Facial plastic surgery, by its nature, is a field that constantly is seeking new and innovative ways of treating patients. This innovation often involves novel techniques and tools. The US Food and Drug Administration is charged with regulating drugs and medical devices to ensure that the public is treated in safe and effective ways. It does not, however, regulate the practice of medicine. Physicians are able to use drugs and devices off-label but are required to follow certain guidelines. This article describes the physician's legal responsibilities and limitations in off-label drug or device use.
Sclafani
Anthony P
AP
Division of Facial Plastic Surgery, Department of Otolaryngology-Head & Neck Surgery, The New York Eye & Ear Infirmary, New York, NY 10003, USA. asclafani@nyee.edu
D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D012941:Social Responsibility; D013518:Surgery, Plastic / Q000941:ethics* / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*