HHS Seeks Public Input to Improve Access to Deceased Donor Islet Cell Treatments

WASHINGTON, D.C.—SEPTEMBER 23, 2026—The U.S. Department of Health and Human Services (HHS), through the U.S. Food and Drug Administration (FDA), today released a Request for Information (RFI), “Improving Patient Access to Deceased Donor Islet Cells and Cell Products,” seeking public input on how the federal government should regulate certain deceased donor islet cells and cell products used to treat type 1 diabetes. The RFI asks whether the current FDA-led biological product framework creates barriers to patient access and whether an alternative transplant-based framework could improve access while maintaining rigorous safety and quality protections.

Under the current framework, therapies made from deceased donor pancreatic islet cells are regulated by the FDA as biological products. FDA’s approval process evaluates product safety, effectiveness, and manufacturing quality, and approved products remain subject to ongoing safety oversight.

“Deceased donor islet cells can give some people with type 1 diabetes the ability to produce insulin again,” said HHS Secretary Robert F. Kennedy, Jr. “HHS is taking a hard look at whether federal regulations unnecessarily stand between patients and these potentially life-changing treatments. We will protect rigorous standards for safety and quality while examining every responsible path to expand access and put patients first.”

Pancreatic islets are clusters of cells that include beta cells, which make insulin. In islet transplantation, cells isolated from a deceased donor pancreas are infused into a recipient, where functioning cells may begin producing insulin and may reduce or, in some cases, eliminate the need for administered insulin.

The RFI specifically seeks comment on whether “unmodified” deceased donor islet cells should be classified as organs for transplantation rather than biological products. Under such an approach, oversight of procurement, allocation, and transplantation could move from FDA’s product-based framework to the Health Resources and Services Administration (HRSA) and the Organ Procurement and Transplantation Network (OPTN). HRSA oversees the OPTN, the national system that sets transplantation policies, maintains the national waiting list, and matches donors with recipients.

HHS is seeking information, including:

• Whether current FDA regulatory requirements create barriers that limit appropriate patient access;
• Whether an organ-transplant framework could improve the efficiency and availability of unmodified deceased donor islet cell transplantation; and
• What safeguards would be needed to protect patients and maintain safety, quality, and accountability under any alternative framework.

HHS has not made a final determination. The RFI is an information-gathering step and does not by itself change the regulatory status of any FDA-approved products, other deceased donor islet cell products, or current federal requirements.

HHS encourages all interested parties to submit comments by November 8, 2026. To review the RFI and submit a response, visit the federal register and reference Docket No. FDA-2026-N-10738.

Additional Resources:

• Request for Information: Improving Patient Access to Deceased Donor Islet Cells and Cell Products
• FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
• Pancreatic Islet Transplantation - National Institute of Diabetes and Digestive and Kidney Diseases
• Organ Procurement and Transplantation Network - Health Resources and Services Administration