The HCT/P Modernization Act of 2025

The HCT/P Modernization Act of 2025 would direct the Food and Drug Administration to improve transparency and education regarding the regulation of human cell and tissue products, which are medical articles containing human cells or tissues intended for use in patients. The bill would require the FDA to conduct workshops with stakeholders, establish a public comment process, and submit a report to Congress with recommendations on how these products should be regulated.

If enacted, the bill would also require the FDA to publish educational materials about its Tissue Reference Group, which advises manufacturers on regulatory questions about these products. For three years, the FDA would need to annually publish data on the number of inquiries received by the Tissue Reference Group, response times, the number of manufacturers registered with the FDA, and inspection information. These requirements would aim to make the regulatory process more transparent and accessible to companies and organizations working with human cell and tissue products.