Year: 2025
Type: article
Abstract: The study by Zapotoczny et al 1 offers an important and timely evaluation of pediatric medical device labeling in the US.By analyzing labeling information for 101 high-risk (class III) devices and reviewing US Food and Drug Administration (FDA) Reports to Congress, the authors show that labeling with meaningful guidance for pediatric use remains limited.Many devices are labeled solely for adults or omit age and weight criteria altogether, even when clinical studies supporting approval included children.These findings highlight gaps that affect not only regulatory clarity but also clinical safety and equity in child health care.Although the analysis presented in the study is highly valuable, an important limitation noted by the authors is that it focuses exclusively on class III devices, which undergo premarket approval and are reported to Congress.In contrast, the majority of devices used in children are class II, which are cleared through the 510(k) or de novo pathways, and many class I devices require only registration and listing.These lower-risk device categories comprise the bulk of medical devices used for children, including many that are essential and lifesaving.As such, the findings represent only a fraction of the broader pediatric device landscape.The challenge related to pediatric device labeling is further compounded by the wide range of subpopulations within the pediatric definition, as outlined in the FDA's Center for Devices and Radiological Health's 2014 guidance on the premarket assessment of pediatric medical devices. 2 These include neonates (birth through 28 days), infants (29 days to less than 2 years), children (2 years to less than 12 years), and adolescents (aged 12 through 21 years), each with distinct physiologic and developmental characteristics that influence device design, testing, and appropriate use.However, other agencies and payers use different age cutoffs, creating inconsistencies that complicate study design, labeling
Source: JAMA Network Open
Author: Kolaleh Eskandanian
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W4416998974