Background: Food and Drug Administration (FDA) regulation of Orthobiologics can be challenging to interpret for the non-regulatory scientist. However, understanding how regulations apply to clinical use of these orthobiologic products is critical, as there are both ethical and legal ramifications to using orthobiologics in conflict with regulations. Recent FDA guidances have attempted to clarify these issues, although questions still remain regarding nuances in regulatory applications.
Methods: FDA guidances, industry blogs, and relevant publications were searched for citations regarding recent orthobiologics and regulations. These sources were compiled into a current assessment of FDA regulations regarding the use of orthobiologics in the shoulder.
Results: Key to understanding these regulations is the FDA differentiation of human cellular and tissue based products (HCTPs) into 361 and 351 category products. While some controversy still exists, FDA has attempted to clarify these issues with several recent guidances. Of equal importance, FDA has ended enforcement discretion for many biologic products in June of 2021, creating a previously tolerated class of orthobiologics that now requires an Investigational New Drug (IND) application and subsequent Biologic License Application to legally market these orthobiologics. The Same Surgical Procedure Exception was further clarified in 2017 to exempt facilities from regulatory controls when specific guidelines are met.
Conclusions: This article attempts to clarify the current thinking on FDA regulations and will allow the shoulder and elbow surgeon to stay within the current bounds of ethical and legal use of these products.
Keywords: FDA; HCTP; human cell and tissue products; orthobiologics; stem cell.
Copyright © 2024. Published by Elsevier Inc.