The HCT/P Modernization Act of 2025

HR 340, the HCT/P Modernization Act of 2025, requires the FDA to improve transparency around the regulation of human cell and tissue products (HCT/Ps), such as tissue transplants and stem cell therapies. The bill mandates the FDA to publish educational resources, annual reports on inspections and inquiries, and establish a public docket for stakeholder input on regulatory updates. These changes aim to streamline oversight for HCT/P manufacturers, researchers, and healthcare providers by making FDA processes more predictable. The law directs the FDA to report to Congress by September 2026 with recommendations for modernizing regulations, considering scientific advances and public health.