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S 3105119th CongressIn Committee
ISLET Act
Introduced: Nov 5, 2025
Sponsor: Sen. Lee, Mike [R-UT] (R-Utah)
Standard Summary
Comprehensive overview in 1-2 paragraphs
The ISLET Act regulates human cadaveric islets for transplantation as organs rather than drugs or biological products.
Key Points
- 1Amends Public Health Service Act to include islets as organs
- 2Clarifies islets are not drugs, biologics, or HCT/Ps
- 3Requires HHS to update relevant regulations within 1 year
- 4Mandates progress report to Congress within 6 months
- 5Applies to pancreatic islet cell transplants
Impact Areas
Organ transplantationDiabetes treatmentBiologics regulationMedical researchHHS regulatory policy
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