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GUIDANCE DOCUMENT

Providing Information about Pediatric Uses of Medical Devices Guidance for Industry and FDA Staff May 2014

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0117
Issued by:
Guidance Issuing Office
Center 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.

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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:

Dockets Management
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.

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