Describing Inconsistencies in Pediatric Labeling of Medical Devices

What are the current pediatric medical device age labeling practices?In this cross-sectional study involving reports from the Food and Drug Administration (FDA) to Congress from 2008 to 2017, 101 unique, high-risk pediatric medical devices were identified, of which only 7.9% used the FDA-recommended age ranges in their Indications For Use statement, whereas 50.5% were labeled for patients aged 18 years and older.These findings indicate that device manufacturers and patients could benefit from FDA-established standardized age-labeling requirements for medical devices, similar to those in drug regulation.

Corresponding Author: Juan Espinoza, MD, Stanley Manne Children’s Research Institute, Ann jespinozasalomon@luriechildrens.org).

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