Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Pediatric device report: FDA submits its first annual 1report to Congress on pre-market approval statistics for pediatric-use devices, posted April 28. The 2007 FDA Amendments Act requires the agency to submit the reports as part of a government effort to encourage development of devices for young patients. During fiscal 2008, FDA approved 15 PMAs and panel-track supplements and two humanitarian-use devices that treat or diagnose conditions with pediatric subpopulations, including Abbott's Freestyle Navigator continuous glucose monitor and Thoratec's Heartmate II left ventricular assist system. Two devices were specifically labeled for use in pediatric patients in FY 2008