The Department of Health and Human Services (HHS) is asking the public whether insulin-producing islet cells from deceased donors should be regulated as organs for transplant rather than as biological products. HHS, through the FDA, released a request for information on September 23, and comments are due November 8, 2026. HHS stressed that it has not made a final decision and that the request does not change any current requirements.
For some people with type 1 diabetes who have repeated, dangerous episodes of low blood sugar, islet transplants can restore some natural insulin production, and some recipients no longer need insulin. Advocates say current rules limit access, while regulators must weigh the procedure's serious risks.
