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BioWorld - Wednesday, December 17, 2025
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Home » PMA study: Most pediatric devices are made for teens, adults
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PMA study: Most pediatric devices are made for teens, adults

June 23, 2021
By Ana Mulero
There is “a wide gap” in the availability of pediatric medical devices that suggest most of these were developed for adolescents, according to a new study on FDA premarket approval applications (PMAs). The findings stem from an evaluation of 297 PMA documents for 149 high-risk devices, 68% of which include pediatric age indications. Pediatric medical devices have lagged behind their adult counterparts in terms of availability, options and innovation. The new findings add to the current relatively limited body of research considering the ample medical device space but are consistent with previous findings that most devices indicated for children are limited to those over 18 years of age.
BioWorld MedTech Neonatal/pediatrics Medical devices U.S. FDA PMA

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