Shandra Eisenga Human Cell and Tissue Product Safety Act
Sponsored By: Senator Peters, Gary C. [D-MI]
Introduced
Summary
This bill would strengthen FDA oversight and public education for human cell and tissue products (HCTPs). It aims to make guidance and data about HCTPs clearer so clinicians, patients, and industry can better understand donation, regulation, and safety.
Show full summary
- Families and health care professionals: Would fund and distribute educational materials on organ, tissue, and eye donation, donor screening tests, and evidence-based ways to approach patients and families.
- Tissue establishments and researchers: Would require the FDA to publish counts of registered HCT establishments and inspections from Jan 1, 2019 onward. It directs the agency to develop best practices, hold workshops, and help generate scientific data with reporting that starts within one year and continues for three years.
- Enforcement and transparency: Would create civil penalties for violations of HCTP rules up to $20,000 per violation and $20,000 per day after written notice, plus the retail value of implicated products, capped at $10.0 million per proceeding. It would also open a public docket and require a report to Congress by Sept 30, 2026 with regulatory recommendations.
Personalized for You
How does this bill affect your finances?
Personalize government policy and PRIA will tell you what this bill means for your household, plus every other piece of legislation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
New civil penalties for tissue sellers
If enacted, this bill would let HHS fine people for certain human cell and tissue product rule violations. Penalties would be $20,000 for each violation. They would be $20,000 more for each day the violation continues after the Secretary gives written notice. The violator would also owe the retail value of the products, and total penalties in one case could not exceed $10,000,000.
Public docket and regulatory workshops
If enacted, the Secretary would open a public docket within 60 days to collect written comments on modernizing rules for human cell and tissue products. The FDA would run workshops and publish best practices to help developers get timely regulatory advice. The Secretary would summarize the workshop and docket and give Congress regulatory recommendations by September 30, 2026. The changes aim to improve regulatory predictability and safe access to these products.
Education on organ and tissue donation
If enacted, the Secretary would support creating and sharing educational materials for health care and other appropriate professionals about organ, tissue, and eye donation. Materials would include evidence-based ways to approach patients and families and information on any donor screening tests. The Secretary would also provide related information sessions to help donors and professionals.
Sponsors & CoSponsors
Sponsor
Peters, Gary C. [D-MI]
MI • D
Cosponsors
Sen. Marshall, Roger [R-KS]
KS • R
Sponsored 6/24/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov