Abstract:

Bone graft materials are subject to various regulatory approval pathways by the FDA (Food and Drug Administration). The expected safety and efficacy of bone grafts may only be clear to FDA reviewers, but difficult for clinical physicians to anticipate. The FDA's regulatory pathways mainly include of four pathways: 510K approval, IDE/PMA (Investigational Device Exemption/Premarket Approval), HTC/P (human cells, tissues, and cellular and tissue-based products), and RMAT (Regenerative Medicine Advanced Therapy). The bone regeneration process involves various growth factors, such as bone morphogenetic proteins-2, 4(BMP-2, 4), fibroblast growth factors, vascular endothelial growth factors, platelet-derived growth factors (PDGF), and insulin-like growth factor-1, etc. Infuse (BMP-2) is a graft material that combines rh-BMP-2 with an absorbable collagen sponge. OP-1 (BMP-7) was approved by the FDA in 2001 to replace autograft in treating recalcitrant long bone nonunions. PDGF-BB materials are made by combining rhPDGF with β-tricalcium phosphate, and were approved by the FDA in 2015 for surgical fusion of ankle. iFactor^TM is a peptide-enhanced bone graft material manufactured by adsorbing P-15 onto inorganic mineral matter and hydrogel carriers, which was approved by the FDA in 2005 for anterior cervical discectomy and fusion in single-level procedures. Four products of rhBMP-2 enhanced bone grafts are approved in China. In comparison with foreign countries, there is a significant gap in the variety of products containing growth factors and bioactive factors in China. The medical device of tissue engineering consist of three basic elements of tissue engineering such as carrier, cell, and growth factors, which were combined effectively, and enhance the scientific content and effectiveness and bone grafts and bone graft substitutes.The National Medical Products Administration should refine the approval pathways for bone graft materials containing growth factors and bioactive molecules based on product composition, improve the timeliness of the regulatory process, and enhance translational scientific level.

Key words: Bone regeneration, Bone graft, Bone graft substitutes, Growth factor, Bone morphogenic protein