Bill > HR8018

This bill, known as the ISLET Act, aims to regulate human cadaveric islets for transplantation as organs. It amends the Public Health Service Act to explicitly include "human cadaveric islets" alongside the pancreas in the context of organ transplantation. Importantly, the bill clarifies that human cadaveric islets will not be considered "drugs," "biological products," or "human cells, tissues, or cellular or tissue-based products (HCT/Ps)" under existing federal definitions, thereby establishing a distinct regulatory pathway for them. The Secretary of Health and Human Services is required to update relevant regulations within one year of the bill's enactment to reflect these changes and must report to Congress on this progress within six months.

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https://www.congress.gov/bill/119th-congress/house-bill/8018/all-info