Pediatric devices

From FDAnews: The device industry and FDA officials recently held a workshop on pediatric device trials, hoping it will spur development and lead to much-needed guidance.

Participants discussed unmet research needs and suggested ways to design clinical trials and measure the safety and effectiveness of devices in a pediatric population. Their comments will be included in an upcoming report and will help the center draft guidance on developing clinical trials for pediatric devices.

The participants also discussed some of the obstacles in developing pediatric devices:

• Scientific data necessary to clinical device development are lacking because of stringent pediatric trial policies and the small pool of potential participants.

• A device registry is needed, but participants questioned the logistics of tracking patients who are regularly on the move and change names.

• Patient demand for pediatric devices is small, so getting companies to fund a costly study can be difficult. The average cost of a clinical trial to bring a new Class III device to market is about $100 million, according to an independent study.