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Guidance Issuing OfficeCenter for Devices and Radiological Health
While the national transplant waiting list continues to grow, donation and transplant rates remain stagnant. The shortage of organs available for transplants has propelled a new wave of innovation in organ preservation technologies. These technologies are evaluated in animal models to demonstrate that they are suitable for clinical experience.
The intent of this guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices. For information regarding Good Laboratory Practice (GLP) requirements that may apply to such studies, you should refer to 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. FDA recommends balancing the ethical principles of The Three R's (replacement, reduction and refinement)1 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.
FDA recognizes that best practices for conducting animal studies to evaluate organ preservation devices are evolving with the rapid advancements in such technologies. This guidance is not intended to be comprehensive or prescriptive. Instead, it aims to highlight FDA's initial thoughts on how animal transplant models can be utilized to evaluate organ preservation technologies, with careful considerations of regulatory least burdensome principles. While FDA expects that at this time, most of these animal studies will be initially submitted to support investigational device exemption (IDE) applications, and may also be used to support premarket approval applications (PMA), premarket notifications (510(k)), humanitarian device exemption (HDE) applications, or De Novo classification requests.
FDA encourages members of industry to submit a Pre-Submission to obtain feedback for specific animal study protocols to evaluate organ preservation devices. For more information on Pre-Submissions, you should refer to Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.
1 Russell WMS, Burch, RL. The Principles of Humane Experimental Technique. London: Methuen & Co.; 1959. Special edition published by Universities Federation for Animal Welfare, 1992. Available online at: http://altweb.jhsph.edu/pubs/books/humane_exp/het-toc.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-4886.