Shandra Eisenga Human Cell and Tissue Product Safety Act

This bill aims to make human cell and tissue transplants safer and clearer for patients and providers. It tells federal health officials to run a national, evidence-based education campaign and to create easy-to-use materials for doctors about organ, tissue, and eye donation and donor screening tests.

It also adds strong fines for breaking safety rules. Violators can be charged up to $20,000 for each violation, another $20,000 for each day the violation continues after written notice, plus the retail value of the products involved, with a maximum of $10 million per case.

To improve oversight and transparency, the FDA must post plain-language materials about its Tissue Reference Group and how to get timely recommendations, publish yearly (for three years) data on registered facilities, inspections, questions sent to the Tissue Reference Group, and response times, and hold workshops to educate patients, providers, and industry. The FDA must also open a public docket within 60 days to gather input on modernizing the rules and report back to Congress with recommendations by September 30, 2026.

• Who is affected: Patients, health care providers, tissue establishments, and the FDA.
• What changes: National education campaign; clear materials for providers; civil penalties for safety violations; FDA website guidance; annual public data; stakeholder workshops; public comment docket; a report to Congress with recommendations.
• When: Public docket within 60 days; website information within 1 year and then annually for 3 years; report due by September 30, 2026.