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# Info Collection on Device Pediatric Subpopulations
- URL: https://www.fdaweb.com/info-collection-on-device-pediatric-subpopulations/
- Published: 2019-12-02T12:00:00.000Z
- Updated: 2026-09-14T15:54:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145617

*Federal Register* notice: FDA is seeking comments on an information collection extension on “Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure Under Section 515A of the Federal Food, Drug, and Cosmetic Act—21 CFR 814 OMB” (Control Number 0910-0748). FDA’s regulations require applicants who submit certain medical device applications to include readily available information providing a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended for, and the number of affected pediatric patients. The information submitted will allow the agency to track the number of approved devices for such conditions or diseases, and the review time for each such device application. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-12-02/pdf/2019-25980.pdf?ref=fdaweb.com).