FDA Commissioner Scott Gottlieb said the agency wants to encourage the development of medical devices designed specifically for pediatric patients and noted “there are still 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, Gottlieb said at an Aug. 13-14 public meeting on pediatric device development at the agency’s White Oak campus in Silver Spring, Maryland.
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. Of the remaining 48 approvals indicated for adults, 42 were determined by internal pediatric experts to have the potential to treat, diagnose or cure a disease which occurs in a pediatric subpopulation.
Gottlieb cited challenges and “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.
He said the agency is increasing the number of medical devices with labeling for pediatric patients by incorporating known information about device effects in other populations to support pediatric indications.
It is also recruiting pediatric experts for FDA advisory panels whenever there is a reasonable likelihood that the device will be used for children.
In addition, the agency is collecting data on the unmet needs for pediatric medical devices and the barriers to the development of new pediatric devices and is taking new steps to protect children who participate in clinical trials, he said.