FDA Regulation of Orthobiologics and the Foot and Ankle Surgeon.

Abstract

Orthobiologics have potential to support clinical practice. Increased use of these products requires the requisite education of the physician for appropriate use in clinical practice. The purpose of this paper was to review current regulation and FDA guidelines on product use as well as design an outline to help guide the foot and ankle surgeon. A literature search including FDA guidelines, industry websites, and relevant product collaterals were reviewed for citations regarding recent orthobiologics and current regulations. These sources were compiled into a current assessment of FDA regulations regarding the use of orthobiologics in the foot and ankle. The Food and Drug Administration (FDA) established general guidelines on product use for clinicians. While controversy exists, the FDA continues to monitor and refine these documents in attempts to clarify and provide updates. We provide a new 5 step tiered classification of orthobiologic materials, based on levels of literature specific to the foot and ankle surgeon. This article outlines the latest rules and regulations with respect to orthobiologics utilized in foot and ankle surgery. We provide a review to assist physicians with understanding these regulations and how to remain compliant with use of orthobiologic products. We provide a system to organize available products based on current data. Although FDA regulation can be overwhelming, foot and ankle surgeons must effectively translate biologic technologies as gatekeepers to the wide array of orthobiologic materials.