Despite Gains, Device Approvals Still Leave Children Behind

Posted July 16, 2019

Approvals of new medical devices aimed at children are on the rise, according to an annual report to Congress published by the Food and Drug Administration (FDA). But while the agency is working to encourage innovation in the pediatric medical device space, premarket device approvals continue to lag compared to their adult counterparts, and especially for young children.

The FDA approved 66 devices through its premarket approval (PMA) and humanitarian device exemption (HDE) programsin the 2017 fiscal year, of which 18 (27%) were indicated for use in a pediatric population. While that is the largest percentage since 2008, the number of pediatric approvals hasn’t kept pace with an overall increase in PMAs and HDEs.

From 2008 to Thinking Big for the Smallest Patients2017, PMA and HDE approvals increased at a rate of 3.8 each year for adult devices compared with an increase of one per year for devices with pediatric indications, according to the report.

“Based on the information summarized in this report, there have been limited changes in PMA or HDE approvals indicated for use in pediatric populations or subpopulations over the last decade,” the report reads. “The number of devices approved for pediatric subpopulations has increased; however, the percentage of devices indicated for use in the pediatric population out of the total devices approved each year has remained relatively constant” at around 24%.

In addition, most PMAs and HDEs that included a pediatric subpopulation were aimed at adolescents, defined as between the ages of 12 and 21. Only 9% of approvals were indicated for use in infants or neonates.

"This report shows that we still have a long way to go when it comes to improving medical devices for children,” said Mark Del Monte, interim CEO and executive vice president of the American Academy of Pediatrics, to MedTech Dive. “In particular, it is important that children can benefit from advancements in medical devices for adults."

Companies that develop pediatric medical devices face multiple hurdles, from practical to financial. Learn more about efforts to improve both the quality and availability of devices for children in AAMI’s award-winning BI&T cover story, “Thinking Big for the Smallest Patients.”