Gottlieb Highlights Agency’s Commitment to New Pediatric Devices

FDA Commissioner Scott Gottlieb said the agency wants to encourage the development of medical devices designed specifically for pediatric patients and said there are “far too few devices on the market designed specifically to treat, diagnose, or cure diseases in children.”

Over the past decade, despite legislation from Congress and regulatory process improvements by CDRH, the number of 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.

In 2017, the agency approved 66 devices through the premarket approval and humanitarian device exemption pathways but only 18 of those were indicated for use in a pediatric population.