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Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2013-D-0117.