This bill, known as the HCT/P Modernization Act of 2025, aims to streamline the regulatory oversight of human cell and tissue products (HCT/Ps) by directing the Secretary of Health and Human Services to implement several key measures. It mandates the Food and Drug Administration (FDA) to publish educational materials about its Tissue Reference Group (TRG) and best practices for obtaining timely, accurate recommendations from this group. This initiative seeks to improve transparency and guidance for stakeholders in the HCT/P sector. The legislation also requires the FDA to annually publish specific data for four years, including the number of registered HCT/P establishments, the inspections conducted, and detailed statistics on TRG inquiries and their average response times. Furthermore, it directs the Secretary to provide comprehensive information and conduct workshops for various stakeholders, such as industry, tissue establishments, and patients, to enhance regulatory predictability and foster scientific advancement in this field. Additionally, the bill establishes a public docket within 60 days to gather written comments on modernizing HCT/P regulation, specifically addressing considerations like "minimal manipulation" and "homologous use." Finally, it requires the Secretary to submit a comprehensive report to Congress by September 2026, summarizing all public input and proposing recommendations for HCT/P regulation, while carefully considering regulatory burden, scientific progress, product access, and the paramount goal of protecting public health.
Administrative law and regulatory proceduresCell biology and embryologyCongressional oversightDepartment of Health and Human ServicesGovernment information and archivesHealth information and medical recordsInternet, web applications, social mediaOrgan and tissue donation and transplantation
The HCT/P Modernization Act of 2025
USA119th CongressHR-340| House
| Updated: 1/13/2025
This bill, known as the HCT/P Modernization Act of 2025, aims to streamline the regulatory oversight of human cell and tissue products (HCT/Ps) by directing the Secretary of Health and Human Services to implement several key measures. It mandates the Food and Drug Administration (FDA) to publish educational materials about its Tissue Reference Group (TRG) and best practices for obtaining timely, accurate recommendations from this group. This initiative seeks to improve transparency and guidance for stakeholders in the HCT/P sector. The legislation also requires the FDA to annually publish specific data for four years, including the number of registered HCT/P establishments, the inspections conducted, and detailed statistics on TRG inquiries and their average response times. Furthermore, it directs the Secretary to provide comprehensive information and conduct workshops for various stakeholders, such as industry, tissue establishments, and patients, to enhance regulatory predictability and foster scientific advancement in this field. Additionally, the bill establishes a public docket within 60 days to gather written comments on modernizing HCT/P regulation, specifically addressing considerations like "minimal manipulation" and "homologous use." Finally, it requires the Secretary to submit a comprehensive report to Congress by September 2026, summarizing all public input and proposing recommendations for HCT/P regulation, while carefully considering regulatory burden, scientific progress, product access, and the paramount goal of protecting public health.
Administrative law and regulatory proceduresCell biology and embryologyCongressional oversightDepartment of Health and Human ServicesGovernment information and archivesHealth information and medical recordsInternet, web applications, social mediaOrgan and tissue donation and transplantation