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Streamlining Islet Cell Transplants: Regulating Cells as Organs, Not Drugs.

This Act aims to improve access to life-saving islet cell transplants, primarily benefiting individuals with Type 1 diabetes. It reclassifies human cadaveric islets as organs for regulatory purposes, rather than treating them as drugs or biological products. This change is intended to simplify the regulatory process, potentially increasing the availability and speed of these critical transplant procedures.
Key points
Human cadaveric islets will be regulated as organs, simplifying complex medical and distribution procedures.
The change explicitly excludes islets from definitions of 'drug,' 'biological product,' and 'HCT/Ps' under federal law.
This regulatory simplification is expected to increase the availability of transplants for patients with Type 1 diabetes.
The Department of Health and Human Services must update all relevant federal regulations within one year.
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Introduced
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Additional Information
Print number: 119_S_3105
Sponsor: Sen. Lee, Mike [R-UT]
Process start date: 2025-11-05
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Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

ISLET Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_S_3105.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2025-11-05.

What are the main provisions?

Key points include:

  • Human cadaveric islets will be regulated as organs, simplifying complex medical and distribution procedures.
  • The change explicitly excludes islets from definitions of 'drug,' 'biological product,' and 'HCT/Ps' under federal law.
  • This regulatory simplification is expected to increase the availability of transplants for patients with Type 1 diabetes.
  • The Department of Health and Human Services must update all relevant federal regulations within one year.
What is the specific legal status?

The current status is Introduced.

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 Sen. Lee, Mike [R-UT].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-23.

CATEGORIES

Health