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HHS/FDA RIN: 0910-AG29 Publication ID: Spring 2011 
Title: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure 
Abstract: The regulation would implement section 515A(a) of the Federal Food, Drug, and Cosmetic Act (added by FDAAA) by amending part 814 to require applicants who submit premarket approval applications (PMAs) or a supplement to an application, product development protocols (PDPs), and applications for humanitarian device exemptions (HDEs) to include readily available information regarding the actual and potential pediatric use of their medical device. These applications must include if readily available: A description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected pediatric patients. The proposed rule does not require additional clinical research or other costly efforts, and simply requires the applicant to briefly summarize readily available information that will have been reviewed by the applicant during the course of its development of the device and preparation of its application to FDA. The information submitted will allow FDA to track the number of approved devices for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure; the number of approved devices labeled for use in pediatric patients; the number of approved pediatric devices that were exempted from a review fee pursuant to section 738(a)(2)(B)(v) of the act; and the review time for each such device. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 814   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 360e    21 USC 360e-1    21 USC 360j    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/01/2010  75 FR 16365   
Direct Final Rule  04/01/2010  75 FR 16347   
NPRM Comment Period End  06/15/2010    
Notice of Withdrawal of Direct Final Rule  07/20/2010  75 FR 41986   
Final Rule  02/00/2012    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Paul Gadiock
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W0-66, Room 4432,
Silver Spring, MD 20993-0002
Phone:301 796-5736
Fax:301 847-8145
Email: paul.gadiock@fda.hhs.gov