The HCT/P Modernization Act of 2025
Sponsored By: Representative Crenshaw
Introduced
Summary
Modernize FDA oversight of human cell and tissue products to increase transparency and make regulation more predictable. This bill would require the Food and Drug Administration to publish guidance, collect public input, run workshops, and deliver recommendations on updating HCT/P rules.
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- Industry and manufacturers would get clearer guidance. The FDA would publish educational materials about the Tissue Reference Group and updated best practices aimed at supporting development of stem cell and other cellular therapies.
- Regulators and the public would see more data. The FDA would post annual information for 4 years on HCT/P establishments registered since Jan. 1, 2019, inspections since that date, the number and type of Tissue Reference Group inquiries, and average response times.
- Researchers, patients, and health systems would gain more input and predictability. The bill would create a public docket within 60 days, require stakeholder workshops, and direct the FDA to report recommendations by Sept. 30, 2026, considering burden, science, access, and public health.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Clearer FDA guidance on cell and tissue products
If enacted, FDA would post plain-language materials about the Tissue Reference Group and how to get timely, accurate advice. FDA would share information with industry, tissue centers, hospitals, research groups, and patients, and hold workshops as needed. The bill would update a 2022 law so best practices focus on how to generate the scientific data needed for stem cell and other cellular therapies. It would also define key terms, including using 21 C.F.R. §1271.3(d) for “human cell and tissue products.”
FDA recommendations to Congress by 2026
If enacted, the Secretary would send Congress a report by September 30, 2026 with recommendations on how to regulate human cell and tissue products. The report would summarize input from the public workshop and docket. It would consider 21 C.F.R. §§1271.10(a) and 1271.3, regulatory burden, new science, access to products under section 361 of the Public Health Service Act, and protecting public health.
More public input and FDA reporting
If enacted, the Secretary would open a public docket within 60 days to take written comments on a planned workshop and on modernizing rules for human cell and tissue products. Comments could address how to assess “minimal manipulation” and “homologous use.” FDA would also post a public report no later than 1 year after enactment, then yearly for 3 more years. Reports would show how many establishments registered on or after January 1, 2019, inspections (with a comparison to blood establishments), Tissue Reference Group inquiries, and average initial and final response times.
Sponsors & CoSponsors
Sponsor
Crenshaw
TX • R
Cosponsors
Barragan
CA • D
Sponsored 1/13/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov