The HCT/P Modernization Act of 2024

HR 8251, the HCT/P Modernization Act of 2024, streamlines regulatory classification for human cell and tissue products (HCT/Ps) like regenerative therapies and tissue grafts. It requires the FDA to respond within 70 days to manufacturers’ inquiries about whether their products fall under the less stringent section 361 of the Public Health Service Act (instead of drug/biologic approval pathways) and mandates a public meeting to clarify definitions of "minimal manipulation" and "homologous use." The bill also directs the FDA to update regulations within 12 months to reduce regulatory burden while maintaining current approval pathways, and requires annual reports to Congress on inquiry volumes and classification decisions. This directly affects manufacturers, tissue banks, and medical researchers developing HCT/P therapies by clarifying regulatory requirements.