Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act

This ICR collects information from medical device manufacturers specifically when submitting a premarket approval application or supplement thereto, premarket notification, or humanitarian device exemption. The guidance document suggests that applicants 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 latest form for Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug and Cosmetic Act expires 2020-06-30 and can be found here.