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Open for comment Health and Human Services Department, Food and Drug Administration, Health Resources and Services Administration Docket Docket No. FDA-2026-N-10738

HHS Seeks Input on Regulating Deceased Donor Islet Cells for Type 1 Diabetes Treatment

💬 Comments close in 42 days (Nov 9)

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  1. Proposed / opened

    HHS Seeks Input on Regulating Deceased Donor Islet Cells for Type 1 Diabetes Treatment

Briefs in this proceeding

High HHS FDA 💬 Comments close in 42 days (Nov 9)

HHS Seeks Input on Regulating Deceased Donor Islet Cells for Type 1 Diabetes Treatment

HHS Request for Information explores whether deceased donor islet cells should be regulated as organs under OPTN policy or as cell products, impacting transplant access and regulatory pathways for Type 1 diabetes therapies. The Department of Health and Human Services (HHS) has opened a public...

Sources

Health and Human Services Department, Food and Drug Administration, Health Resources and Services Administration · Improving Patient Access to Deceased Donor Islet Cells and Cell Products; Request for Information · Sep 24