HR 340119th CongressIn Committee

The HCT/P Modernization Act of 2025

Introduced: Jan 13, 2025

Standard Summary

Comprehensive overview in 1-2 paragraphs

The HCT/P Modernization Act of 2025 directs the Secretary of Health and Human Services, through the FDA, to modernize and streamline the regulatory oversight of human cell and tissue products (HCT/Ps). Key aims include improving transparency, providing better educational resources about how the FDA’s Tissue Reference Group (TRG) works, and increasing predictability for stakeholders involved in HCT/Ps. The bill also updates the regulatory framework by updating how “best practices” are described in law to emphasize generating scientific data to facilitate development of HCT/Ps, and it creates new opportunities for public input through a docket and a congressional report due in 2026. Overall, the measure seeks to balance patient safety with a more transparent, data-driven, and predictable regulatory environment for HCT/Ps, including stem cell therapies.

Key Points

1Public education and guidance: The Secretary must publish on FDA’s website educational materials about the Tissue Reference Group and best practices for obtaining timely, accurate TRG recommendations on HCT/Ps.
2Transparency and metrics: Within one year after enactment and for the next three years, the Secretary must publicly report on (a) HCT/P establishments registered since Jan 1, 2019; (b) FDA inspections of HCT/P establishments since Jan 1, 2019 (with a comparison to blood establishment inspections); (c) the number and type of inquiries to the TRG; and (d) average TRG submission response times (initial and final).
3Stakeholder education and engagement: The Secretary must provide information to industry stakeholders and patients and conduct workshops and interactive sessions to support regulatory predictability and scientific advancement.
4Regulatory framework update: The act amends the Food and Drug Omnibus Reform Act of 2022 to replace “best practices” with language focused on generating scientific data necessary to facilitate development of certain HCT/Ps and to reflect the latest information about these products, including stem cell therapies.
5Public input and reporting: The Secretary must establish a public docket within 60 days to receive comments on approaches for TRG discussions and on modernizing HCT/P regulation, including considerations related to minimal manipulation and homologous use; and by September 30, 2026, must report to Congress with recommendations on regulating HCT/Ps, taking into account regulatory burden, scientific developments, access to 361-regulated products, and public health protection.

Impact Areas

Primary group/area affected- Human cell and tissue product developers and tissue establishments (e.g., banks, manufacturers, and clinics) and FDA regulators, who will experience enhanced transparency, new reporting requirements, and a clarified pathway for interaction with the TRG.Secondary group/area affected- Patients and patient advocates, healthcare providers, academic health centers, biomedical consortia, and research organizations, who may benefit from better information, educational resources, and more predictable regulatory timelines.Additional impacts- Regulatory transparency and predictability: More public data and stakeholder engagement could improve understanding of the regulatory process and timing.- Data-driven modernization: Emphasizing generation of scientific data may accelerate development of HCT/Ps, including stem cell therapies, while still preserving safety and public health protections.- Burden and process considerations: The public docket and report to Congress could influence future regulatory burdens and approaches; the focus on minimal manipulation and homologous use will shape how certain products are regulated under 21 CFR 1271.3.

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