H.R. 1082 · Passed House · Health

Shandra Eisenga Human Cell and Tissue Product Safety Act

Sponsor: John R. Moolenaar (R-MI)

What it does

• Establishes civil penalties for violating FDA regulations on donor eligibility and good tissue practice for human cell and tissue products.
• Requires the FDA to hold workshops for stakeholders on the science and regulation of these products and to open a public docket for comments.
• Requires an FDA report to Congress with recommendations on regulating these products.
• Requires the FDA to support educational materials for health care professionals on organ, tissue, and eye donation.
• Requires the FDA to publish educational materials about the Tissue Reference Group and best practices for seeking its recommendations.

Official 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…

Latest action

Jun 24, 2025: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Committee: Senate Health, Education, Labor, and Pensions