Off-Label Use in Orthopaedic Surgery

Benjamin C. Taylor, MD; Jacob J. Triplet, DO; Taleed El-Sabawi, MS, JD


J Am Acad Orthop Surg. 2019;27(17):e767-e774. 

In This Article

Medical Device Regulation act of 1976

Signed into law on May 28, 1976, by President Gerald R. Ford, the Medical Device Amendments of 1976 of the Federal Food, Drug, and Cosmetic Act of 1938 delegated that the FDA help regulate the safe use of medical devices.[3] Provisions of this act outline three categories pertaining to medical devices[4] (Table 2). Class I devices (general controls) are those that are deemed low risks for human use with a reasonable assurance of safety and efficacy; devices in this category must be free of life-supporting or impairment-preventing responsibilities. Class II devices (performance standards) are considered as moderate risks for human use, demonstrating insufficient assurance of the safety and efficacy. Finally, class III devices (premarket approval) are considered as high risks for human use and often have life-supporting or impairment-preventing responsibilities. Device classification is dependent on the indications and applications of its use. Common orthopedic devices are found in Title 21 of the Code of Federal Regulations Part 888.[5]

Following FDA approval, manufacturers are restricted to promoting the use of the device for the approved indication(s). Although the manufacturer is regulated in the promotion of the device for FDA-approved indications, the orthopedic surgeon has the discretion to use the device in a non–FDA-approved fashion; this is branded as "off-label" use.[4,6,7] This is also true for prescription drugs and biologics.[8,9] Off-label use has been recognized by the federal government as acceptable when the device is used in the best interest of the patient.[4,5,7,10] However, it is the responsibility of the treating surgeon to be familiar with the product's use and effects and to base its off-label use on clinical and scientific rationale.[6,11]