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

 
• 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 July 26, includes data through FY 2015, which was a record-setting year overall for original PMA approvals. (Also see "FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal

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