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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.
article Official text account_balance Process page
Passed House
Citizen Poll
No votes cast
Additional Information
Print number: 119_HR_1082
Sponsor: Rep. Moolenaar, John R. [R-MI-2]
Process start date: 2025-02-06
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Shandra Eisenga Human Cell and Tissue Product Safety Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_1082.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2025-02-06.

What are the main provisions?

Key points include:

  • 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.
What is the specific legal status?

The current status is Passed House.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Moolenaar, John R. [R-MI-2].

What is the latest detailed status?

The latest detailed status is: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-22.

CATEGORIES

Health