This bill, known as the ISLET Act , aims to reclassify and regulate human cadaveric islets specifically for transplantation purposes. It amends the Public Health Service Act to include these islets in the definition of organs , thereby subjecting them to organ transplantation regulations. A crucial provision of the bill explicitly states that human cadaveric islets are not to be considered a drug , biological product , or human cells, tissues, or cellular or tissue-based products (HCT/Ps) . This reclassification is intended to provide a clear regulatory pathway for their use in life-saving endocrine transplantation. The Secretary of Health and Human Services is mandated to update all relevant regulations within one year to implement this change and report on the progress of these updates within six months of the bill's enactment.
This bill, known as the ISLET Act , aims to reclassify and regulate human cadaveric islets specifically for transplantation purposes. It amends the Public Health Service Act to include these islets in the definition of organs , thereby subjecting them to organ transplantation regulations. A crucial provision of the bill explicitly states that human cadaveric islets are not to be considered a drug , biological product , or human cells, tissues, or cellular or tissue-based products (HCT/Ps) . This reclassification is intended to provide a clear regulatory pathway for their use in life-saving endocrine transplantation. The Secretary of Health and Human Services is mandated to update all relevant regulations within one year to implement this change and report on the progress of these updates within six months of the bill's enactment.