Few pediatric devices were approved after a clinical trial involving children


Many devices approved for pediatric use were not tested in a clinical trial involving children.

Medical devices are often not given proper testing for pediatric use, lacking clinical evidence that they are both safe and effective on children, according to researchers from Harvard Medical school. To find out more, these investigators examined high-risk cardiovascular devices approved by the US Food and Drug Administration (FDA) for use in children and adolescents.

Data was taken from the premarket approval and humanitarian device exemption databases from the years 1977 to 2021. This data revealed which high-risk cardiovascular devices were FDA-approved. According toa research letter from the Journal of the American Medical Association, only 8.6% of the devices approved in the study period were also approved for pediatric use. Most of these devices were for all pediatric ages,except forone-third of the devices being approved only for patients aged 18 years and older.

Investigators noted that many of the high-risk cardiovascular devices used in children are repurposed from those used in adults. Of the devices approved for pediatric use, less than half were tested in a clinical trial involving children. Because of this, the researchers concluded that more regulatory processes and industry assessments would be necessary fordevices to be properly evaluated for use in children.

Of the devices that were approved for pediatric use, many were defibrators, stents, and prosthetic valves. Almost half were implantable, and over 40% were considered lifesaving. As not many studies were required to enroll children, further evidence was not collected. This factor was made worse by the low completion rate for these studies.

Given the unique anatomy of children and adolescents compared to adults, the investigators recommended further studies to collect evidence on the effectiveness and safety of pediatric devices.


Wunnava S, Miller TA, Narang C, Nathan M, Bourgeois FT. US Food and Drug Administration approval of high-risk cardiovascular devices for use incChildren and adolescents, 1977-2021. JAMA. 2022;328(6):580–582. doi:10.1001/jama.2022.10041

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