# Federal Register #FDA-2026-N-10738

HHS Request for Information on Regulation of Deceased Donor Islet Cells and Cell Products for Type 1 Diabetes

**Buyer:** Department of Health and Human Services
**Posted:** September 24, 2026
**Respond By:** November 09, 2026
**Identifier:** FDA-2026-N-10738

HHS is seeking public input to guide its regulatory approach for deceased donor islet cells and cell products used in Type 1 diabetes treatment.
- Government Buyer:
  - Department of Health and Human Services (HHS)
    - Food and Drug Administration (FDA)
    - Health Resources and Services Administration (HRSA)
- OEMs and Vendors:
  - Lantidra (islet cell product)
- Products/Services Requested:
  - No specific products or purchase quantities requested
  - Focus is on regulatory standards, frameworks, and data for islet cell therapies
- Unique/Notable Requirements:
  - Seeking data on standards for transplantation, product development, and safe use
  - Considering whether unmodified deceased donor islet cells should be classified as organs
  - Potential impacts on procurement, allocation, and transplantation under Organ Procurement and Transplantation Network (OPTN) policies
  - Input requested on regulatory precedents, operational changes, patient access, provider participation, and program costs
  - Reference to Lantidra as an FDA-licensed islet cell product
- No procurement of products or services; this is a request for information to inform future regulation

### Description

The Department of Health and Human Services (HHS) is soliciting input, supporting data, and comments to assist in determining the best regulatory approach for deceased donor islet cells and cell products used in treating Type 1 diabetes. The request seeks information on establishing standards for transplantation and development of these cells and products, and whether unmodified deceased donor islet cells should be defined as organs. This reclassification would impact procurement, allocation, and transplantation under the Organ Procurement and Transplantation Network (OPTN) policies and require new standards and surveillance.

[View original listing](https://www.federalregister.gov/documents/2026/09/24/2026-19563/improving-patient-access-to-deceased-donor-islet-cells-and-cell-products-request-for-information)