The Regulatory Environment for Tissue-Engineered Products for the Treatment of Burns in the United States

Background: Tissue engineering (TE) is defined by the National Institutes of Health as the practice of combining scaffolds, cells, and biologically active molecules into functional tissue with the goal of restoring, maintaining, or improving damaged tissue or whole organs. In the burns treatment landscape, skin substitutes, human tissue, and other products are being developed to provide dermal replacement, prevent infection, and prevent or mitigate scarring. Skin substitutes can vary in composition (cellular vs acellular), in origin (human, animal, or synthetically derived), in processing (minimal vs extensive), and in complexity (dermal-only vs composite).

The regulation of skin substitutes in the United States (US) occurs by one of several pathways established by the US Food and Drug Administration (FDA), including a Biological License Application (BLA), a 510(k) submission (class I, II), a Premarket Approval Application, or a Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/P) designation (Section 351 or Section 361 of the Public Health Service Act), based on the criteria of minimal manipulation and homologous use. 

Key differentiators among these regulatory classifications include the amount and type of data required to support each regulatory pathway. For example, a BLA for a biological TE product requires a clinical trial(s) and evaluation of safety and efficacy by the Center for Biologics Evaluation and Research (CBER). Applicable CBER-approved biological products must comply with the advertising and promotional labeling regulations defined in the Code of Federal Regulations. 

Purpose: A description of, and associated requirements for, the various regulatory pathways governing FDA-authorization approval or clearance of TE products was presented. We also explored some of the regulatory challenges facing TE products in the context of skin substitutes for the treatment of burns.

*Poster is not available at this time.