Requests that the FDA to reclassify unmodified deceased donor (allogeneic) pancreatic islet cells as human organs for purposes of transplantation, and to transfer their regulatory oversight from the FDA's biologic drug licensing framework to the organ transplantation framework administered by the Health Resources and Services Administration, the Organ Procurement and Transplantation Network. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-7930

Requests that the FDA to reclassify unmodified deceased donor (allogeneic) pancreatic islet cells as human organs for purposes of transplantation, and to transfer their regulatory oversight from the FDA's biologic drug licensing framework to the organ transplantation framework administered by the Health Resources and Services Administration, the Organ Procurement and Transplantation Network.

Documents

Comments

Key Dates

Comment Period OpensJul 24, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Citizen Petition from Jerri Groth	Jul 24, 2026	--

Keywords

CBER

Citizen Petition

to reclassify

unmodified deceased donor allogeneic

pancreatic islet cells as human organs for

purposes of transplantation

and to transfer their regulatory

oversight from the FDAs biologic drug licensing

Data from Regulations.gov