Regulatory Focus™ > News Articles > FDA Reports on FY2016 Pediatric Device Approvals

FDA Reports on FY2016 Pediatric Device Approvals

Posted 25 August 2017 | By Michael Mezher 

FDA Reports on FY2016 Pediatric Device Approvals

In a report to Congress released this week, the US Food and Drug Administration (FDA) says it approved 13 high-risk medical devices for pediatric patients in FY2016, the highest number since 2011 when 15 were approved.

Under the Food and Drug Administration Amendments Act of 2007 (FDAAA), device makers are required to include information in premarket approval (PMA) and humanitarian device exemption (HDE) applications about pediatric subpopulations that are affected by a disease or condition their device is intended to treat, whether or not the device is indicated for pediatric patients.

FDAAA also requires FDA to report to Congress each year on the number of devices approved with a pediatric indication as well as the number of devices approved that are indicated to treat a condition that also affects pediatric populations.

In FY2016, FDA approved 68 new PMAs and three HDE applications, the vast majority of which were indicated for a disease that also affects a pediatric subpopulation.

Of those, 13 PMA devices were approved with a pediatric indication, though all but three of those were for older pediatric patients.

Two of those devices, Zoll's LifeVest Wearable Defibrillator and Animas' Vibe System, are indicated solely for pediatric patients, and as a result were exempted from paying user fees.

Compared to FY2015, FDA approved slightly more PMA and HDE applications in FY2016, both as a whole and for pediatric use, but took slightly longer to do so—with a median of 180 review days and 267 total elapsed days versus 179 and 237 days in the previous year.

While most of the devices with pediatric indications were approved within the agency's review goal of 180 days, three devices took much longer (Medtronic's MiniMed 630G System, 338 days; STORZ Medical's Duolith SD1 Shock Wave Therapy, 679 days; and the LifeVest Wearable Defibrillator, 1031 days). Only one device, Medtronic's MiniMed 670G System, was approved in much less time, at 103 review days.


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