Gottlieb Discusses Challenges of Developing Pediatric Devices

August 15, 2018

Speaking at a public meeting on pediatric medical device development, FDA Commissioner Scott Gottlieb discussed challenges the agency faces in the development of medical devices designed specifically for pediatric patients.

Gottlieb cited “practical roadblocks” surrounding the development of pediatric medical devices. “One issue is the obvious — there are physical differences between children and adults that can affect development. There are also higher costs sometimes associated with development of medical devices for any affected population of a small size, and especially those designed for a pediatric market.”

Over the past decade, despite legislation from Congress and regulatory process improvements by CDRH, novel medical devices designed, evaluated, and approved for pediatrics is only about a quarter of those for adults and the majority of pediatric approvals are not for children under 18 years of age, Gottlieb said.

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