FDA to Draft Guidance Soon for Pediatric Device Trials

The device industry and FDA officials hope a recent workshop on pediatric device trials will spur development and lead to much-needed guidance. Participants discussed unmet research needs and suggested ways to design clinical trials and measure safety and effectiveness of devices in a pediatric population. With information from the workshop, CDRH can get the ball rolling to address the issues, Barbara Buch, clinical deputy division director for surgical, orthopedic and restorative devices at CDRH, said.
Clinical Trials Advisor