Help Expand Access to Islet Transplantation for Type 1 Diabetes

Did you know that human pancreatic islet cells used for transplantation are currently classified as biologic products or drugs? This classification has created regulatory barriers that limit their availability for life-changing transplantation in type 1 diabetes (T1D).

Now, leaders in diabetes care, researchers, advocacy organizations, and people living with T1D are working to change that. The goal is to have deceased-donor islets regulated as transplanted human organs, like hearts or kidneys, rather than as drugs or biologic products.

You can help move this effort forward. The U.S. Food and Drug Administration (FDA) is accepting public comments on the proposed reclassification of donor islets through November 8, 2026.

Submitting a comment took me just a few minutes — your voice can help support change, too.

What should you include in your comment?

Consider asking the FDA to:

• Regulate human pancreatic islet cells as transplanted human organs — not as drugs or biologics
• Reduce regulatory barriers that limit the availability of donor islets for transplantation and research
  
• Support access at academic research centers so researchers can study islet transplantation and help advance treatment options for people with T1D
  
• Improve insurance coverage and reimbursement by treating islet transplantation like other organ transplants
  
• Help make islet transplantation more affordable and accessible for people who may benefit from this treatment

You don’t need to be an expert or write a lengthy statement. Simply share why this issue matters to you and why improving access to islet transplantation is important.

How to submit your comment

Visit the FDA’s federal public comment portal and follow these steps:

• Enter the docket ID in the search bar: fda-2026-n-10738
• Complete the comment form
• Click “Submit Comment”

Why does this matter?

Islet transplant remains extremely limited in the U.S. For some people with T1D, it may offer an important treatment option, but regulatory barriers can make it harder to access and study.

If the FDA changes regulations on human pancreatic islet cells, it could help expand their availability, support research, improve insurance reimbursement, and promote affordability.

Your voice matters. Submit your comments by November 8, 2026, and help encourage a regulatory approach that could improve access to islet transplantation for people living with T1D.

You can read more about human islet transplantation in T1D Exchange’s interview with Katie Beth Hand.