The HCT/P Modernization Act of 2025
The HCT/P Modernization Act of 2025
Plain Language Summary
# HCT/P Modernization Act of 2025 Summary **What It Does:** This bill asks the FDA to improve how it communicates with and educates the public and medical professionals about human cell and tissue products—materials used in medical treatments that contain human cells or tissues. The bill requires the FDA to hold educational workshops, create a public comment system, and publish guidance materials to help stakeholders understand the current regulations and best practices for these products. **Who It Affects:** The bill impacts medical researchers, healthcare companies, doctors, patients who may receive cell and tissue treatments, and the general public.
It's designed to make FDA information more accessible and transparent for anyone involved in or affected by cell and tissue-based medical products. **Key Provisions:** The FDA must conduct workshops to discuss advancing the science behind these products, establish an online public comment system, publish educational materials about the FDA's "Tissue Reference Group" (an advisory body), and submit a report to Congress with recommendations on how to better regulate these products. These activities must continue for at least three years. **Current Status:** The bill is currently in committee, meaning it's in the early stages of review and has not yet been voted on by the full House of Representatives.
CRS Official Summary
The HCT/P Modernization Act of 2025This bill requires the Food and Drug Administration (FDA) to provide information to stakeholders and report on the regulation of human cell and tissue products, also referred to as human cells, tissues, or cellular or tissue-based products (HCT/Ps), which are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.The bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion with them on advancing the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and submit to Congress a report with recommendations on regulating these products. Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining a recommendation about products from them. Also, annually for three years, the FDA must publish on its website information on the inquiries submitted and average response times for the Tissue Reference Group, as well as the number of human cell and tissue manufacturers that have registered with the FDA and the number of inspections the FDA has conducted with respect to these manufacturers since 2019. (The Tissue Reference Group is a working group within the FDA that receives product-specific questions from, and provides recommendations for, stakeholders on the regulation of human cell and tissue products under the FDA’s rules.)
Latest Action
Referred to the House Committee on Energy and Commerce.