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

ABSTRACT:

Importance

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.

Objective

To identify and characterize high-risk devices with pediatric age indications derived from PMA statements.

Design, setting, and participants

In this cross-sectional study of PMA statements, those statements containing the words indicated or intended for medical devices listed in the FDA PMA database as of February 2020 were retrieved. Age indications were manually annotated in these approval statements via PubAnnotation. Based on the PMA identification from the PMA state

SUBMITTER: Lee SJ 

PROVIDER: S-EPMC8220494 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature