Comments Sought on Device Pediatric Use Information

Federal Register Notice: FDA is seeking comments on an information collection extension request related to a guidance on “Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.” The guidance suggests that applicants who submit certain medical device applications include, if readily available, pediatric use information for diseases or conditions that the device is being used to treat, diagnose, or cure that are outside the device’s approved or proposed indications for use, as well as an estimate of the number of pediatric patients with such diseases or conditions. The information submitted will allow FDA to identify pediatric uses of devices outside their approved or proposed indication for use to determine areas where further pediatric device development could be useful. To view the notice, click here.