Issue Date: May 1, 2014
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Pediatric Product Development
Status: Final
Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff
Section 302 of Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA), created Section 515A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e-1). Section 515A requires submitters to FDA of premarket approval applications (PMAs), supplements to PMAs, humanitarian device exemptions (HDEs), and product development protocols (PDPs) for new devices to include readily available information about pediatric subpopulations that suffer from a disease or condition that the device is intended to treat, diagnose, or cure. This guidance document describes how to compile and submit the readily available pediatric use information required under Section 515A of the FD&C Act.
Download the Guidance Document
