Federal Register: HRSA (340B, workforce) · September 24, 2026 · Primary source
Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information
Summary
HHS has opened a public docket via the Federal Register requesting information on how to regulate deceased donor islet cells and islet cell products for treatment of Type 1 diabetes. The agency seeks input on whether these therapies should be subject to differing regulatory frameworks depending on whether they are isolated and unmodified versus more processed products. HHS is specifically exploring whether unmodified deceased donor islet cells should be classified as organs under OPTN policy and regulated by HRSA, which would impose new standards for processing, isolation, quality, and transplant program oversight.
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