Article authors call for advance planning of oversight for long-term donor organ storage
Article authors call for advance planning of oversight for long-term donor organ storage
On September 13, 2026, Avi Roy drew attention to a boundary in regulatory oversight: FDA rules for cells and tissues exclude vascularized donor organs. The closest FDA example describes a device that prepares a liver for transplantation, rather than an organ that has undergone long-term storage.
After retrieval, a donor organ is usually cooled and transplanted promptly. Machine perfusion adds a preparation step: a device pumps an oxygenated solution through the organ to sustain it until surgery.
In a January FDA letter, the VitaSmart HOPE system received De Novo classification, a pathway for new types of medical devices. The device treats a donor liver after conventional cold storage; the FDA document specifies requirements for component sterility and perfusion parameters.
In § 1271.3, the FDA defines HCT/P as human cells, tissues, and cellular and tissue-based products. The regulation explicitly excludes vascularized organs for transplantation, meaning organs with blood vessels, from the HCT/P category.
The authors of the article consider a different scenario: an organ undergoes complex preparation and is stored for substantially longer than usual, after which its function is restored before transplantation. If extended biopreservation becomes clinically available, physicians deciding whether an organ is suitable for a particular patient will need information about its preparation, storage, and recovery.
“Realizing the long-term benefits of advanced biopreservation methods requires advance planning for legal and ethical oversight; that process should begin now.”
The authors propose quality oversight, specialized centers for storage and recovery, data sharing, and rules for allocating organs between immediate transplantation and storage. In their view, the FDA could clarify whether the longstanding HCT/P exclusion applies only to conventional storage; another option would be legislation enacted by Congress.