More than eight out of 10 high-risk devices approved through premarket approval for pediatric use were not studied in patients less than 18 years old, according to a study in Pediatrics.
Researcher identified 25 devices that received either premarket approval or humanitarian device exemption pathway from the U.S. Food and Drug Administration for therapeutic use in children from 2008 to 2011.
Twenty-two of these devices qualified as pediatric devices even though they were only approved for patients 18 years or older. Additionally, 84 percent of the devices (21) were not studied in any patients less than 18 years of age.
The FDA required postmarketing studies for 19 devices, but only three of those studies required enrolling pediatric patients.
While the FDA Center for Devices and Radiologic Health still considers patients between 18 and 21 years old as pediatric, authors noted that the device approvals were only tested in a small number of pediatric patients.
"Both [physicians and patients] deserve rigorous evidence to make informed treatment decisions that adequately weigh the benefits and risks of a device.... Future efforts to address the lack of evidence to guide the use of devices in children should place greater emphasis on studying the devices in pediatric patients both in premarket and postmarketing trials," researchers suggested, according to a Medscape report.
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