Postmarketing trials and pediatric device approvals.

ABSTRACT:

Background

Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development. The current state of trial evidence underpinning the approval of pediatric devices remains poorly described.

Methods

We identified all high-risk (ie, class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. We collected key information on clinical trial design (randomization, blinding, controls, and types of end points) as well as age distribution of trial participants. We also identified US Food and Drug Administration (FDA)-manda

SUBMITTER: Hwang TJ 

PROVIDER: S-EPMC4531281 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature