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Cell and Tissue Product Safety: Increased Awareness and Penalties for Violations

This Act enhances the safety of cell and tissue transplants by mandating a national, evidence-based education campaign for citizens and healthcare providers regarding the risks and benefits. It also introduces severe civil penalties (up to $10 million) for entities that violate safety regulations concerning these products. Citizens will benefit from better access to information about donation and procedure safety, aiming to protect public health.
Key points
Public Education: Implementation of an awareness campaign on the risks and benefits of human cell and tissue product transplants, targeting patients and healthcare professionals.
Higher Penalties for Violations: Establishment of new, high civil penalties (up to $20,000 per day of violation, maximum $10 million per proceeding) for companies failing to comply with safety regulations for cell and tissue products.
FDA Guidance Review: Requirement for the FDA to review and update existing guidance for donor eligibility, including recommendations to reduce the risk of transmitting tuberculosis and sepsis.
Increased Transparency: The FDA must publish data on inspections of tissue establishments, the number of registrations, and response times for inquiries regarding cell and tissue products.
article Official text account_balance Process page
Expired
Citizen Poll
No votes cast
Additional Information
Print number: 118_HR_7188
Sponsor: Rep. Moolenaar, John R. [R-MI-2]
Process start date: 2024-02-01
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Summarized by: gemini-flash-latest
Source data: api.congress.gov
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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 118_HR_7188.

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 2024-02-01.

What are the main provisions?

Key points include:

  • Public Education: Implementation of an awareness campaign on the risks and benefits of human cell and tissue product transplants, targeting patients and healthcare professionals.
  • Higher Penalties for Violations: Establishment of new, high civil penalties (up to $20,000 per day of violation, maximum $10 million per proceeding) for companies failing to comply with safety regulations for cell and tissue products.
  • FDA Guidance Review: Requirement for the FDA to review and update existing guidance for donor eligibility, including recommendations to reduce the risk of transmitting tuberculosis and sepsis.
  • Increased Transparency: The FDA must publish data on inspections of tissue establishments, the number of registrations, and response times for inquiries regarding cell and tissue products.
What is the specific legal status?

The current status is Expired.

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, as amended Agreed to by voice vote. (text: CR H7167-7168)

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-30.

CATEGORIES

Health Courts and Law