# Understanding the Shandra Eisenga Human Cell and Tissue Product Safety Act

This bill is about making sure people understand the risks and benefits of getting transplants made from human cells and tissues, and it strengthens the rules for companies that produce these products. Human cell and tissue products include things like donated organs, tissues, and eye transplants, as well as newer treatments made from stem cells and other cellular therapies. Right now, many people and even some healthcare providers don't fully understand what these products are, how safe they are, or what could go wrong.

The bill requires the federal government to launch an education campaign to inform both the general public and healthcare professionals about organ, tissue, and eye donation. This campaign will explain how to approach patients and families about donation, what screening tests are available for donors, and other important facts about the donation process. The goal is to make sure that when someone is considering a transplant or donation, they have accurate, science-based information to make that decision.

The bill also adds real consequences for companies that break the rules. If a company that produces these products violates federal regulations, they can now be fined up to $20,000 per violation, plus an additional $20,000 for each day the violation continues. They also have to pay the retail value of any contaminated or improper products. However, the total penalty in any single case can't exceed $10 million. This gives the government stronger enforcement tools to hold companies accountable if they cut corners on safety.

Finally, the bill requires the FDA to make information more accessible and transparent. The agency must publish educational materials about how to get approval for new cell and tissue products, post statistics about inspections and registrations, and hold workshops to help companies and researchers understand the rules. The FDA also has to gather public input about how to modernize these regulations and report back to Congress with recommendations by September 2026. Essentially, this bill aims to make the system clearer for everyone involved—patients, doctors, companies, and regulators—while strengthening safety standards.

Shandra Eisenga Human Cell and Tissue Product Safety Act

Moolenaar, John R.

Shandra Eisenga Human Cell and Tissue Product Safety ActThis bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also&nbsp;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&nbsp;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)&nbsp;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&nbsp;tissue manufacturers.&nbsp;