The ISLET Act (Increase Support for Life-saving Endocrine Transplantation Act) changes how human cadaveric islets—insulin-producing cells from deceased donors used to treat diabetes—are regulated. Currently, these islets are classified as drugs or biological products, which creates regulatory barriers; this bill reclassifies them as organs instead, similar to how pancreases are already treated. The change affects people with type 1 diabetes and severe type 2 diabetes who could benefit from islet transplantation, as well as researchers and transplant centers working in this field. The bill requires the Department of Health and Human Services to update its regulations within one year to implement this new classification and report progress to Congress within six months. The goal is to streamline the regulatory process and increase access to this potentially life-saving transplant procedure.
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