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The HCT/P Modernization Act of 2025
2/11/2025, 5:53 AM
Summary of Bill HR 340
Specifically, the bill calls for the Secretary of Health and Human Services to carry out activities that will streamline the regulatory oversight of human cell and tissue products. This includes developing and implementing processes to expedite the review and approval of these products, as well as ensuring that regulations are clear and consistent.
In addition to streamlining regulatory oversight, the bill also addresses other purposes related to human cell and tissue products. These purposes may include improving access to these products for patients in need, promoting innovation in the development of new products, and ensuring the safety and effectiveness of these products. Overall, Bill 119 HR 340 aims to enhance the regulatory framework for human cell and tissue products in order to better serve patients, promote innovation, and ensure the safety and effectiveness of these important medical products.
Congressional Summary of HR 340
The HCT/P Modernization Act of 2025
This 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.)
