HHS Asks Whether Donor Islet Cells for Type 1 Diabetes Should Be Regulated as Organs

The Department of Health and Human Services (HHS) published a request for information on September 24, 2026, asking how deceased-donor islet cells for type 1 diabetes (T1D) should be regulated. The notice, issued jointly by the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA), sets no rule. It opens a public docket, with comments due November 9, 2026, and floats an unusual idea: treating unmodified donor islet cells as organs rather than as biological products.

What the notice covers

T1D is a chronic autoimmune disease in which the immune system destroys the insulin-producing beta cells of the pancreas. The notice says it affects more than 2 million people in the United States. Islet therapy uses cells from the pancreata of deceased donors, and the notice describes it as an option for eligible patients who meet strict criteria.

According to the notice, FDA has so far licensed one such product: Lantidra, an allogeneic pancreatic islet cellular therapy used together with immunosuppression. It is indicated for adults with T1D who cannot approach target HbA1c because of repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Under current rules, a sponsor wanting to market an unmodified deceased-donor islet product must file a biologics license application (BLA). The notice adds that most islet transplants today are done under an investigational new drug (IND) application.

The two questions HHS is asking

1. Could public data replace some of the usual evidence? HHS asks whether enough publicly available information exists to set standards for these products, which “could streamline sponsor development and FDA evaluation” of BLAs. The notice points to a precedent: in 1998 FDA collected outcome data on unrelated donor cord blood products, reviewed it with the published literature, and concluded that safety and effectiveness had been established for certain products. It then issued guidance for sponsors relying on that data.

The questions are specific. They ask whether reproductive, developmental and carcinogenicity studies should be waived for conventional islet products, and whether animal safety studies of the standard delivery route (percutaneous transhepatic portal vein) should be waived. They ask which real-world data would count, naming the Collaborative Islet Transplant Registry (CITR), the UK Transplant Registry/NHS Blood and Transplant, and the Edmonton Protocol cohort at the University of Alberta. They also ask whether FDA should keep the primary endpoint from its 2009 islet guidance, a composite of HbA1c of 6.5% or lower and elimination of severe hypoglycemia, and whether an external historical control would be sufficient.

2. Should unmodified islet cells be organs? HHS asks about defining them as organs. Procurement, allocation and transplantation would then follow policy of the Organ Procurement and Transplantation Network (OPTN) and be overseen by HRSA rather than FDA. The notice states that this would require OPTN to set standards for safety, effectiveness, processing and isolation quality, and surveillance, as well as training requirements for transplant surgeons and physicians in designated islet programs.

What the notice does and does not show

This is a request for information, not a finding. HHS does not claim that current data establish safety or effectiveness; it asks the public whether such data exist. Nor does it present evidence that FDA rules are the cause of limited access. It asks for that evidence: commenters are invited to provide “quantitative data or documented evidence” showing that FDA requirements, “rather than manufacturing capacity, reimbursement, clinical infrastructure, donor availability, or other factors,” are the primary cause.

The notice itself flags limits in the evidence it might draw on. International cohorts may have been generated under frameworks that treat islets as tissue or organ products, so their outcomes data may be informative while their manufacturing data may not meet current standards for biological products. It also asks how well those cohorts generalize to U.S. patients, given possible differences in HbA1c targets and hypoglycemia thresholds.

Risks the notice lists

• Bleeding, blood clots, allograft rejection and loss of graft function.
• Risks related to immunosuppression, including the “long-term burden of lifelong immunosuppression.”
• Communicable disease transmission, manufacturing variability, sterility and potency, if oversight moved out of the biological product framework.

HHS also asks for current data on graft durability beyond 5 years and how it weighs against long-term immunosuppression. The notice does not supply those figures.

What remains unknown

• Whether HHS will change anything. The notice says it seeks information “before determining whether any changes to the current oversight framework are warranted.”
• How reclassification would affect access, cost and insurance coverage. HHS lists treatment center numbers, patient travel, waiting times, patient costs and coverage as questions, not answers.
• The effect on organ transplant patients. The notice says over 100,000 people are on the organ waiting list, and OPTN is funded mainly by patient registration fees; it asks what reclassification would do to OPTN operations and finances.
• Any timetable beyond the November 9 comment deadline.

Why it matters beyond islet cells

The notice itself asks what precedent classifying islets as organs could set for other donor-derived cellular products and future cell-based therapies. It also asks whether an OPTN framework built for vascularized organs suits processed cellular therapies at all. For people with T1D and severe hypoglycemia, the practical stake is how, and how quickly, a therapy that exists today could become available outside research settings. That depends on answers HHS has not yet received.

Comments may be submitted at regulations.gov under Docket No. FDA-2026-N-10738.

General information, not medical advice. Talk with your care team about diabetes treatment options.

Source: HHS, FDA and HRSA, “Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information,” Federal Register, September 24, 2026.