Shandra Eisenga Human Cell and Tissue Product Safety Act

House Bill

H.R. 1082

119th Congress

Shandra Eisenga Human Cell and Tissue Product Safety Act

In Committee

Introduced:Feb 6, 2025

Primary Sponsor

Christopher H. Smith

Representative

Republican

NJ-4

Cosponsors

1

Quick Stats

Policy Area

Health

Summary

The Shandra Eisenga Human Cell and Tissue Product Safety Act establishes civil penalties for violations of FDA regulations on human cell and tissue products used in transplants and medical procedures. It requires FDA workshops, educational materials for healthcare professionals, transparency about the Tissue Reference Group, and annual reporting on tissue manufacturer registrations and inspections.

Latest Action

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

AI Summary

Plain-English explanation of this bill

The Shandra Eisenga Human Cell and Tissue Product Safety Act establishes civil penalties for violations of FDA regulations on human cell and tissue products used in transplants and medical procedures. It requires FDA workshops, educational materials for healthcare professionals, transparency about the Tissue Reference Group, and annual reporting on tissue manufacturer registrations and inspections.

Last updated: 12/30/2025

Official Summary

Congressional Research Service summary

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 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.

Key Points

Main provisions of the bill

Creates civil penalties for tissue product violations
Requires FDA workshops on tissue product regulation
Mandates educational materials for healthcare professionals
Increases transparency about Tissue Reference Group
Annual reporting on tissue manufacturer inspections
Improves donor eligibility and handling standards

How This Impacts Americans

Potential effects on citizens and communities

This bill strengthens oversight of human cell and tissue products used in medical procedures. Named for a patient harmed by unregulated tissue products, it creates enforcement teeth through civil penalties that currently do not exist for tissue handling violations. Enhanced FDA education and transparency help healthcare providers understand tissue product safety. The bill addresses a regulatory gap that has allowed some unsafe practices in the growing regenerative medicine field.

Policy Areas

Primary Policy Area

Health

Related Subjects

Administrative law and regulatory procedures

Civil actions and liability

Congressional oversight

Department of Health and Human Services

Health programs administration and funding

Health promotion and preventive care

Organ and tissue donation and transplantation

Scope & Jurisdiction

Jurisdiction Level

federal

Congressional Session

119th Congress

Citation Reference

1082, 119th Congress (2025). "Shandra Eisenga Human Cell and Tissue Product Safety Act". Source: Voter's Right Platform. https://votersright.org/bills/118-hr-1082