Food and Drug Administration's Position on Commonly Injected Biologic Materials in Orthopaedic Surgery.

Fang, William H; Vangsness, C Thomas

The use of biologically based therapies is becoming a popular less-invasive therapy for relieving pain and promoting tissue regeneration. The most commonly used biologics are autologous adipose-derived products, bone marrow aspirations, and platelet-rich plasma (PRP). Birth tissue is a common allogenic source of biologics, including umbilical cord, placental membranes, and amniotic fluid. Injected biologics, depending on the indication and how they are processed, formulated, delivered, and promoted, can be subject to different regulatory pathways. The aim of this review is to provide an overview of these products and procedures and educate the musculoskeletal community about the relevant current Food and Drug Administration (FDA) regulations.