FDA Recommends Risk-Based Animal Testing of Organ Preservation Devices

Developers of medical devices designed to preserve organs for transplant should carefully evaluate the risk of injury to the organs as they test the devices with animal subjects, whether they measure outcomes in vivo or ex vivo, the FDA says in new draft guidance.

Each of those approaches offers pluses and minuses, the agency says.

When blood supply is restored to an organ ex vivo — in an isolated setup — to test device effectiveness, more detailed information can be collected in a more controlled environment, the guidance says. But the accuracy of that data in predicting how the organ would fare in an actual transplant is unclear, the guidance says.

In vivo testing, in which the organ is translated into a living recipient animal, offers more direct assessment of results. But that method involves lots of variables unrelated to the functioning of the device that can cloud the meaning of the outcomes, the FDA said.

Read the draft guidance here: www.fdanews.com/09-14-17-AnimalStudies.pdf. — Gregory Roberts