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Enhanced Safety and Transparency for Human Cell and Tissue Transplants.

This Act mandates a national education campaign to inform the public and healthcare providers about the risks and benefits of human cell and tissue transplants. It significantly increases civil penalties for companies that violate safety regulations concerning these products, aiming to enhance public health protection. The law also requires greater transparency in the FDA's oversight of tissue establishments.
Key points
Mandatory national education campaign for the public and medical staff on safe tissue donation and transplant procedures.
Introduction of severe financial penalties (up to $10 million) for entities violating safety rules for cell and tissue products.
Increased FDA oversight transparency: required publication of data on tissue establishment inspections and regulatory response times.
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Status:
Passed House
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Additional Information
Shandra Eisenga Human Cell and Tissue Product Safety Act
Print number: HR 1082
Sponsor: Rep. Moolenaar, John R. [R-MI-2]
Process start date: 2025-02-06