Shandra Eisenga Human Cell and Tissue Product Safety Act

Summary

Shandra Eisenga Human Cell and Tissue Product Safety Act This bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also requires the Food and Drug Administration (FDA) to report on the regulation of these products and to provide related information to stakeholders. ( Human cell and tissue products are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.) Specifically, the bill establishes civil penalties for violations of the FDA’s regulations on donor eligibility and current good tissue practice for manufacturing and distributing human cell and tissue products. Also, the bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion on 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 report to Congress with recommendations. The bill also requires the FDA to support the development of educational materials for health care professionals regarding organ, tissue, and eye donations and related topics. Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group (a working group within the FDA) and best practices for obtaining a recommendation from them about human cell and tissue products. Also, annually for three years, the FDA must publish on its website information on inquiries submitted to the Tissue Reference Group and FDA registrations and inspections regarding human cell and tissue manufacturers.

Summary from the Congressional Research Service. How we handle summaries

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Where it stands

Passed one of the two chambers; it still needs the other.

House Committee on Energy and Commerce · U.S. House of Representatives

Full history

1. Jun 24, 2025

   Sent to the executive

   Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   U.S. Senate

2. Jun 24, 2025

   In committee

   Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   U.S. House

3. Jun 23, 2025

   Considered Under Suspension of the rules. (consideration: cr H2860-2862)

   Considered under suspension of the rules. (consideration: CR H2860-2862)

4. Jun 23, 2025

   Considered Under Suspension of the rules. (consideration: cr H2860-2862)

   Considered under suspension of the rules. (consideration: CR H2860-2862)

5. Jun 23, 2025

   Debate - the House Proceeded With Forty Minutes of Debate on H.R. 1082.

   DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.

   U.S. House of Representatives