Snapshot: US Pediatric Device Approvals Stay Steady, Despite Overall FDA Surge

27 Jul 2017

• By David Filmore

The 18% of FY 2015 PMA and HDE device approvals that included pediatric indications was the lowest proportion since FY 2009, even while, overall, 2015 was a record-setting year for novel device approvals.

A recent surge in novel device approvals by US FDA did not include a proportionate spike in new devices with pediatric indications, according to recently released data from the agency.

FDA must send a report annually to Congress detailing devices approved with pediatric indications. The latest report, posted...