Feds Seek Ideas on Dead Donor Cells to Treat Type 1 Diabetes
Published Date: 9/24/2026
Notice
Summary
The government wants your ideas on how to make it easier and safer for people with Type 1 diabetes to get special cells from deceased donors that help manage their disease. They’re thinking about new rules to treat these cells like organs, which could improve how they’re shared and used. If you have thoughts, send them by November 9, 2026—this could change how patients get life-changing treatments and how doctors handle them.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 3 costs, 1 mixed.
Reclassifying Islet Cells as “Organs”
HHS is considering defining unmodified deceased donor pancreatic islet cells as “organs.” If that happens, procurement, allocation, and transplantation of those islet cells would be regulated by the Organ Procurement and Transplantation Network (OPTN) under HRSA rather than by the FDA, and the OPTN would need to establish standards for safety, effectiveness, manufacturing quality and consistency, communicable disease control, surveillance, and training/experience of transplant surgeons and physicians.
Medicare Coverage Limited to NIH Trials
Under Section 733 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Centers for Medicare & Medicaid Services (CMS) is required to cover the costs of pancreatic islet cell transplantation only when the transplant is performed in the context of an NIH-sponsored clinical trial.
FDA May Set Public Product Standards
FDA is requesting input on whether there is enough publicly available clinical and nonclinical data to establish public product standards (for example, potency specifications and viability thresholds) for deceased donor islet cell products. If feasible, FDA could derive standards from aggregated real-world evidence to support Biologics License Applications (BLAs) and streamline sponsor development, similar to an approach FDA used for cord blood products.
Potential New Postmarket Reporting Requirements
HHS is considering requiring manufacturers or health care facilities to submit postmarketing data, including clinical outcome data (e.g., graft failure, infections), mandatory adverse experience reports per 21 CFR 600.80, biological product deviation reports (submitted on Form FDA 3486) within 45 calendar days as required by 21 CFR 600.14, annual product quality reviews (21 CFR 211.180(e)), and contributions of standardized outcome data to registries such as the Collaborative Islet Transplant Registry (CITR).
Organ Waitlist Registration Fees Support OPTN
Patients added to the national organ transplant waiting list (including those needing a pancreas transplant) are charged a registration fee when added to the list, and those registration fees support most of the annual costs of operating the Organ Procurement and Transplantation Network (OPTN).
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