Bill sets fines up to $20,000 for tissue product safety violations
Passed one chamberH.R. 1082Latest action
Sponsor: John R. Moolenaar · Representative · MI
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Official title: Shandra Eisenga Human Cell and Tissue Product Safety Act
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
The plain-language version comes first. The official text is always the reference.
HR 1082 adds fines and FDA transparency rules for human tissue products like donated skin, bone, and tendons.
40-second read · 5 questions answered below
What does this do?
The bill requires HHS to run a public education campaign on the risks, benefits, and screening of human cell and tissue products. It also creates financial penalties for safety rule violations and directs the FDA to publish more information about inspections and facility oversight, plus report to Congress by September 2026.
Who does it affect?
Patients receiving tissue-based treatments, healthcare providers, tissue banks and processing companies, and FDA regulatory staff are affected.
Why does it matter?
The changes aim to hold tissue processors accountable for safety lapses and give patients, providers, and Congress clearer information about how the industry is regulated.
What does it cost, and who pays?
- Fines up to $20,000 per violation
- Extra daily penalties possible
- Repayment capped at $10 million per case
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Where does it stand?
- IntroducedFeb 6, 2025
- House committee
- House vote
- SenateYou are here · Jun 24, 2025
- The president's desk
Right now: it passed the House, and the official record shows nothing new since. If the Senate changes it, it goes back to the House before reaching the president.
Latest action: — Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.