Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.

Abstract

Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed. To identify and characterize high-risk devices with pediatric age indications derived from PMA statements. In this cross-sectional study of PMA statements, those statements containing the words indicated or intended fo