> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Organ Preservation Device Guidance Out
- URL: https://www.fdaweb.com/organ-preservation-device-guidance-out/
- Published: 2017-09-14T12:00:00.000Z
- Updated: 2026-09-14T22:50:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139636

FDA has issued a draft guidance, *Utilizing Animal Studies to Evaluate Organ Preservation Devices*, to give recommendations about best practices for using animal studies to evaluate organ preservation devices. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM575922.pdf?ref=fdaweb.com) says a shortage of organs available for transplant has propelled a wave of innovation in organ preservation technologies. It says that such technologies are evaluated in animal models to demonstrate that they are suitable for clinical experience.

The guidance says FDA recommends balancing the ethical principles of replacement, reduction, and refinement, as well as regulatory least burdensome principles, with the goal of using the minimum number of animals necessary to generate data to demonstrate device safety. “You should consider the best practices for the development, conduct, and presentation of these animal studies while incorporating modern animal care and use strategies,” the document says.

Because the technology for evaluating organ preservation devices is rapidly advancing, the agency says, the guidance is not intended to be comprehensive or prescriptive. Rather, it highlights the agency’s initial thoughts on how animal transplant models can be used to evaluate organ preservation technologies, with careful consideration of regulatory least burdensome principles.