To gather public input on the regulation of deceased-donor islet cells and related cellular products for treating type 1 diabetes.
Approach:
Regulatory Review: HHS, through FDA, is examining whether current regulations create barriers to accessing deceased donor islet cell therapies and if a transplantation model could improve access.
Key Findings:
FDA currently regulates deceased donor islet cells as biological products, assessing safety, effectiveness, and manufacturing quality.
HHS is considering whether unmodified deceased donor islet cells should be classified as organs for transplantation, which could shift oversight from FDA to HRSA and OPTN.
Interpretation:
HHS is evaluating the potential for regulatory changes to enhance patient access to islet cell treatments while maintaining safety and quality standards.
Limitations:
The RFI is an information-gathering measure and does not change the regulatory status of existing products.
Conclusion:
HHS encourages public comments by November 8, 2026, to inform potential regulatory adjustments.
