ISLET Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- 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, clarifying that islets are not considered drugs or biological products. The bill also directs the Department of Health and Human Services to update regulations related to organ transplantation to accommodate this new classification and requires a report to Congress on the progress of these updates.
Key provisions
- Includes human cadaveric islets within the definition of organs for transplantation.
- Clarifies that islets are not considered drugs or biological products.
- Directs the Secretary of Health and Human Services to update relevant regulations.
- Sets a deadline of 1 year for the Secretary to update regulations.
- Requires the Secretary to report to Congress on regulatory updates within 6 months.
Who is affected
- Patients with diabetes who require islet transplantation
- Organ donation organizations
- The Department of Health and Human Services
- Pharmaceutical companies
- Medical researchers
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.
4 on record
Primary sponsor
Cosponsors
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