The ISLET Act clarifies the federal regulatory treatment of human cadaveric islets (insulin-producing cells from donated pancreases) by designating them as organs rather than drugs or biological products. This change removes islet transplants from stricter pharmaceutical regulations and places them under the organ transplant framework, similar to how whole pancreases are currently regulated. The bill affects people with type 1 diabetes and other conditions who may benefit from islet transplantation, as well as transplant programs and the medical industry involved in processing and distributing these tissues. The Department of Health and Human Services must update its regulations within one year of the law's enactment and must report to Congress on its progress within six months. No specific funding is allocated in the bill.
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