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FDA Reports Uptick in Pediatric Device Approvals

Sept. 1, 2017

The FDA approved a total of 71 premarket approval applications and humanitarian device exemption applications for pediatric use in 2016 — up from 61 approvals in 2015, the agency reported, in a newly released annual report to Congress.

The FDA approved more of such applications last year than it has in any of the past nine years.

The majority of approvals (68) were for PMAs, with only 3 being HDEs. The number of applications for treating, diagnosing, or curing a disease or condition within a subpopulation of pediatric patients totaled 65.

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