Bills · S 3105
IN COMMITTEE· 119TH CONGRESS
Senate BillS 3105Health
ISLET Act
INTRO NOV 5· LAST ACTION NOV 5
READING
2MIN
COSPONSORS
3
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 2 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenThis bill matters because it could significantly impact the availability and accessibility of islet transplantation for people with type 1 diabetes. Currently, the classification of human cadaveric islets can place them under rigorous regulatory frameworks designed for drugs or biologics, which involve extensive clinical trials and approval processes that can be costly and time-consuming. By reclassifying them as organs, the bill aims to place them under a different regulatory system, one focused on the safe procurement, allocation, and transplantation of donor organs.
If this bill becomes law, it could accelerate the adoption and use of islet transplantation as a standard treatment option, potentially offering a better quality of life and reduced reliance on insulin injections for many patients. If it doesn't pass, islet transplantation would continue to be subject to the existing, potentially more restrictive, regulatory pathways, which could slow down research, development, and patient access, keeping it from becoming as widely available as other organ transplants.
KEY PROVISIONS
4AI-extractedPROVISION 01
The bill officially changes federal law to regulate human cadaveric islets for transplantation in the same way as other organs.
This provision fundamentally shifts how these cells are overseen, moving them from drug-like regulation to organ-like regulation.
PROVISION 02
It explicitly clarifies that human cadaveric islets are not considered 'drugs,' 'biological products,' or 'human cells, tissues, or cellular or tissue-based products' under existing federal definitions.
This ensures that islets will not be subject to the potentially more stringent and lengthy approval processes associated with those categories.
PROVISION 03
The Secretary of Health and Human Services is required to update all relevant regulations within one year to reflect the new classification.
This ensures that the practical rules and procedures for handling islet transplants are promptly adjusted to align with the new legal classification.
PROVISION 04
The Secretary of Health and Human Services must report to Congress within six months on the progress of updating these regulations.
This provides oversight and accountability, ensuring that the required regulatory changes are being made in a timely manner.
SPONSORSHIP
1 + 3
R· Utah
YRS IN OFFICE
15
BILLS LED
138
COSPONSOR BREAKDOWNBIPARTISAN · 0%
DEM 0 REP 3 IND 0
ACTION TIMELINE
2 EVENTSNOV 5
Introduced in Senate
NOV 5
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
BILL INFO
TypeSenate Bill
NumberS 3105
Congress119th
StatusIn Committee
IntroducedNov 5, 2025
Last actionNov 5, 2025
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IN COMMITTEE· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED NOV 5, 2025
Senate BillS 3105Health
ISLET Act
INTRODUCED NOV 5, 2025· LAST ACTION NOV 5, 2025
PASSAGE CHANCES
—%
READING
2 min
COSPONSORS
3
COMPLEXITY
Moderate
