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# FDA Approved 13 PMAs for Pediatric Use in FY 2016
- URL: https://www.fdaweb.com/fda-approved-13-pmas-for-pediatric-use-in-fy-2016/
- Published: 2017-08-24T12:00:00.000Z
- Updated: 2026-09-14T22:43:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139466

A CDRH [report](https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM572980.pdf?ref=fdaweb.com) submitted to Congress shows that in FY 2016, FDA approved 68 original and panel track supplement PMA applications and three humanitarian device exemption (HDE) applications. Of the 71 total approvals, 13 PMAs and none of the HDEs were indicated for use in a pediatric population or subpopulation. And of the 71 total approvals, two were intended solely for pediatric use and thus were exempted from user fees.

Of the 71 total approvals, the report says, 62 PMAs and all three HDEs were approved to treat, diagnose, or cure a disease or condition that occurs within a pediatric subpopulation.

The median time to review the 13 PMAs labeled for use in a pediatric population was 180 FDA days and 267 total elapsed review days.