Comments Sought on Device Pediatric Info Collection

Federal Register Notice: FDA is seeking comments on an information collection related to “Medical Devices; 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— 21 CFR Part 814.” The agency’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 to treat, diagnose, or cure, and the number of affected pediatric patients. The information submitted will allow FDA to track the number of approved devices for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure and the review time for each such device application. To view the notice, click here.