Home » CDRH: Research Needed to Explore Side Effects of Pediatric Devices
CDRH: Research Needed to Explore Side Effects of Pediatric Devices
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
Devices & Diagnostics Letter
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