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HHS/FDA RIN: 0910-AG29 Publication ID: Fall 2009 
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 is implementing section 515A(a) by requiring applicants who submit premarket approval applications (PMAs), product development protocols (PDPs), and applications for humanitarian device exemptions (HDEs) to include readily available information regarding the potential pediatric use of their medical device. These applications must include: 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 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: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 814.1(a)    21 CFR 814.2    21 CFR 814.20(b)(3)(i)    21 CFR 814.37(b)    21 CFR 814.39(h)    21 CFR 814.44(e)(1)    21 CFR 814.100(a)(c)    21 CFR 814.104(b)    21 CFR 814.116(c)    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Title III of the Food Drug Administration Amendments Act of 2007, which includes new section 515A, is also known as the pediatric Medical Device Safety and Improvement Act of 2007.   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2010    
Direct Final Rule  09/00/2010    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: Undetermined 
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