FDA Finalizes Guidance for Utilizing Animal Studies to Evaluate Organ Preservation Devices

Today, the U.S. Food & Drug Administration (FDA) is issuing the final guidance Utilizing Animal Studies to Evaluate Organ Preservation Devices. With the current wave of innovation in organ preservation technologies evaluated in animal models, comes the challenge of demonstrating that these new technologies are sufficiently safe for human clinical use. This final guidance provides relevant information industry should consider when utilizing animal studies to evaluate organ preservation devices. The final guidance provides: Best practices for utilizing animal studies for the evaluation of organ preservation devices. Information to balance the ethical principles of the Three R’s (replacement, reduction and refinement) and regulatory least burdensome principles, with the goal of using the minimum number of animals necessary to generate data to demonstrate device safety. This is a “leapfrog” guidance, and while final, it is intended to provide the FDA’s initial thoughts on an emerging technology and new clinical application that is likely to be of public health importance very early in product development. Therefore, the FDA’s recommendations may change as more information becomes available.

Read the Final Guidance Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or DICE@fda.hhs.gov.