# 2026-19563: Feds Seek Ideas on Dead Donor Cells to Treat Type 1 Diabetes

2026-19563, Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration, Health Resources and Services Administration published 2026-09-24, effective Either electronic or written comments on the notice must be submitted by November 9, 2026.; PRIA reads it as touching household money (as of 2026-10-01).

- Canonical: https://policyrisk.com/federal-register/2026-19563
- As of: 2026-10-01
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-19563
- Title: Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration; Health Resources and Services Administration
- Citation: 91 FR 60632
- Published: 2026-09-24
- Effective: Either electronic or written comments on the notice must be submitted by November 9, 2026.
- Comments close: 2026-11-09
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-10-01

## In one line

Feds Seek Ideas on Dead Donor Cells to Treat Type 1 Diabetes

## 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.

## Abstract

The Department of Health and Human Services (HHS) is opening a public docket to solicit input, supporting data, and comments to assist HHS as it considers how best to regulate deceased donor islet cells and/or deceased donor islet cell products for the treatment of Type 1 diabetes (T1D). The purpose of this information is to allow HHS agencies to better understand how best to regulate these therapies, including whether and how regulation could differ between isolated and otherwise unmodified deceased donor islet cells and deceased donor islet cell products. In this request for information, HHS will specify the type where appropriate or will refer to both types under the umbrella term of islet therapies. HHS seeks information on whether sufficient publicly available information exists to establish standards for how to transplant deceased donor islet cells and/or develop deceased donor islet cell products, as well as whether other publicly available data exist to support their safe and effective use. Additionally, HHS seeks input on the possibility of defining unmodified deceased donor islet cells as organs, which would allow the procurement, allocation, and transplantation of these cells to be performed in accordance with applicable Organ Procurement and Transplantation Network (OPTN) policy and regulated by HRSA. Doing so would require OPTN establishing appropriate standards for safety, effectiveness, quality and consistency of islet cell processing and isolation, and surveillance and policies regarding the training and experience of transplant surgeons and transplant physicians in designated pancreatic islet cell transplant programs.

## Effects PRIA read

- Reclassifying Islet Cells as “Organs”: mixed, high. 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…
- FDA May Set Public Product Standards: benefit, medium. 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 re…
- Medicare Coverage Limited to NIH Trials: cost, high. 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 clinic…
- Organ Waitlist Registration Fees Support OPTN: cost, low. 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).
- Potential New Postmarket Reporting Requirements: cost, medium. 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 c…

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## Sources
- [2026-19563 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/24/2026-19563/improving-patient-access-to-deceased-donor-islet-cells-and-cell-products-request-for-information)
- [2026-19563 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-24/pdf/2026-19563.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-19563 (as of 2026-10-01).