Editorial Commentary: Food and Drug Administration Regulation of Biologics in Orthopaedics: Am I the Only One Around Here Who Gives a Flip About the Rules?!?!

Abstract

As orthobiologics have appeared and stayed a part of our clinical practices, at times it seems that we (orthopaedic surgeons) have not focused appropriate attention and/or interest on regulation. However, regulation has focused on us, as the Food and Drug Administration (FDA) has made it clear. Safety and efficacy are top priorities of the FDA and should be ours too. The FDA has transmitted their communications to industry and to clinicians; we are responsible for understanding their regulations and the FDA definitions of relevant terms, including "minimal manipulation" and "homologous" use. Finally, FDA "clearance" does not mean safe or efficacious, nor compliant with other federal regulations.