FDA Plans Survey of Barriers to Pediatric Device Market

The FDA is planning to survey medical devicemakers and other “key stakeholders” to identify barriers that prevent developers from entering the pediatric device market as well as “incentives that would motivate them to innovate and sustain within this market.”

Despite numerous legislative, regulatory, and scientific efforts, “there has been little change in the number of devices approved for use in pediatric patients, which has led to devices intended for adults being adapted for children without “an appropriate level of evidence, exposing them to inconsistent benefit risk profiles,” the agency said.

To address the issue, the FDA plans a 30-minute phone survey of executives from companies either producing products in pediatrics or from companies that produce products that could be used in pediatrics.

A separate one-hour online survey will include leaders in pediatric companies and other decision makers in the pediatric medical device industry including venture capitalists, banking investors, leaders in children’s hospitals and research networks and pediatric patient advocates.