CDRH: Research Needed to Explore Side Effects of Pediatric Devices

April 8, 2010
With no pediatric circulatory support devices on the market, CDRH is struggling to create a clear approval path for the life-saving products while getting answers about potential neurological side effects. Since one clinical trial is under way and others are expected in the next few years, the agency turned to industry to help it determine to what extent neurological function and neurocognitive assessments should be tied into clinical trials supporting market approval of the devices that are used while children await heart transplants.
Devices & Diagnostics Letter