ISLET Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill, the ISLET Act, aims to specifically regulate the transplantation of human cadaveric islets – small clusters of cells from the pancreas – as organs. It modifies existing law to include islets within the definition of organs, ensuring they are treated similarly to other organs for transplantation purposes. The bill also directs the Department of Health and Human Services to update regulations to accommodate this change and report back to Congress on their progress.
Key provisions
- Defines human cadaveric islets as a type of organ for transplantation.
- Amends the Public Health Service Act to include islets in existing definitions.
- Excludes islets from definitions of ‘drug,’ ‘biological product,’ and ‘HCT/Ps’.
- Requires the Secretary of Health and Human Services to update regulations within one year.
- Mandates a report to Congress within six months regarding regulatory updates.
Who is affected
- Transplant recipients
- Organ donation organizations
- The Department of Health and Human Services
- Pharmaceutical companies
- Medical device manufacturers
Notable changes
- Expands the definition of ‘organ’ to include human cadaveric islets.
- Creates a specific regulatory pathway for islet transplantation.
Bill text
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Sponsors
Official sponsors from legislative records.
7 on record
Primary sponsor
Cosponsors
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