Guidance for Industry  
and FDA Staff 
 
Pediatric Expertise 
for Advisory Panels 
 
 
Document Issued on: June 3, 2003
 
 
For questions regarding this document, contact Geretta Wood, at (301) 594-2022, ext. 133. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
  Office of Device Evaluation 
Office of In Vitro Diagnostic Device Evaluation  and Safety 
  Contains Nonbinding Recommendations 
 
Preface 
 
 
Public Comment 
 
Comments and suggestions may be submitted at any time for Agency consideration to 
Dockets Management Branch, Division of Management Systems and Policy, Office of 
Human Resources and Management Services, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting comments, please 
refer to the exact title of this guidance document.  Comments may not be acted upon by the 
Agency until the document is next revised or updated.   
 
Additional Copies 
 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ode/guidance/1208.pdf, or to receive this document via your fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone.  Press 1 to enter the system.  At the second voice prompt, press 1 to 
order a document.  Enter the document number (1208) followed by the pound sign (#).  
Follow the remaining voice prompts to complete your request.   
 
 
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  Contains Nonbinding Recommendations 
 
Guidance for Industry and FDA Staff 
 
Pediatric Expertise for Advisory Panels 
 
This guidance represents the Food and Drug Administration's (FDA's) current 
thinking on this topic.  It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.  You can use an alternative approach if the 
approach satisfies the requirements of the applicable statutes and regulations.  If you 
want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance.  
 
Introduction 
The purpose of this guidance is to describe internal office procedures to ensure that an 
advisory panel reviewing a premarket submission or other regulatory documents includes 
or consults with one or more pediatric experts, when appropriate.  These premarket 
submissions may include premarket approval applications (PMA) or premarket 
notification submissions (510(k)).  These regulatory documents may include general or 
device-specific guidance documents. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical 
device regulation.  This guidance reflects our careful review of the relevant scientific and 
legal requirements and what we believe is the least burdensome way for you to comply 
with those requirements.  However, if you believe that an alternative approach would be 
less burdensome, please contact us so we can consider your point of view.  You may send 
your written comments to the contact person listed in the preface to this guidance or to the 
CDRH Ombudsman.  Comprehensive information on CDRH's Ombudsman, including 
ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/ 
 
  Contains Nonbinding Recommendations 
 
Background 
On October 26, 2002, the Medical Device User Fee and Modernization Act of 2002 
(MDUFMA) was signed into law.  MDUFMA amended section 515(c) of the Federal, 
Food, Drug, and Cosmetic Act (the act), Application for Premarket Approval to read, in 
part: Where appropriate, the Secretary shall ensure that such panel includes, or consults 
with, one or more pediatric experts.  This is one of several provisions in MDUFMA 
intended to promote the development of safe and effective pediatric devices and to 
protect this vulnerable patient population during the course of clinical trials involving 
such products.  This guidance puts procedures in place to implement this new provision.  
A collateral guidance document, which we are currently developing, will address the 
other related provisions of MDUFMA. 
 
Pediatric Populations 
For purposes of this guidance, we are defining pediatric subpopulations as shown below.   
 
Pediatric Subpopulation  Approximate Age Range 
newborn  birth to 1 month of age 
infant  1 month to 2 years of age 
child  2 to 12 years of age 
adolescent  12-21 years of age 
 
Although the upper age limit used to define the pediatric population varies among 
experts, including adolescents up to the age of 21 is consistent with the definition found 
in several well-known sources.1,2,3  The Center for Devices and Radiological Health 
(CDRH) believes this age range is generally appropriate for the use of medical devices in 
pediatric subpopulations, but recognizes that there may be cases in which the pediatric 
population should be defined differently, depending upon the type of device.  
 
Circumstances Requiring Pediatric Expertise 
Although MDUFMA amended the premarket approval section of the statute, CDRH will 
include pediatric expertise on an advisory panel, when appropriate, for all types of premarket 
submissions (i.e., PMA, product development protocol (PDP), 510(k), humanitarian device 
exemption (HDE), de novo applications, and investigational device exemption (IDE)).  We 
will also include pediatric expertise on advisory panels when we seek panel 
recommendations for other documents, e.g., device-specific guidance documents, 
reclassification petitions.  Therefore, the executive secretary of the panel, following 
consultation with the team leader and division management, should arrange for a pediatric 
expert to be consulted or included in panel deliberations for any of the above submissions or 
documents when:  
 
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  Contains Nonbinding Recommendations 
 
  There are labeled indications for use that include a pediatric subpopulation or there is 
a reasonable likelihood that the device would be used in a pediatric subpopulation for 
the labeled indication; 
 
  There are data in the study that include a pediatric subpopulation; 
 
  There is a reasonable likelihood that the data from the study in the adult population 
may be used by the applicant to subsequently support a pediatric indication; 
 
  There is a need for advisory panel input on a study design and/or protocol for use of 
the device in the pediatric population; or 
 
  There is a reasonable likelihood that the advisory panel may discuss the potential use 
of the device in the pediatric population. 
 
Advisory Panel Readiness 
The Medical Device Advisory Committee will have a cadre of special government 
employees (SGEs) with pediatric expertise who have already been appointed to serve on 
one of its 18 advisory panels.  In addition, CDRH may utilize pediatric expertise available 
on advisory committees of the Center for Drug Evaluation and Research (CDER) and the 
Center for Biologics Evaluation and Research (CBER)  The Office of the Director, Office 
of Device Evaluation (ODE) or Office of In Vitro Diagnostic Device Evaluation and Safety 
(OIVD) will recruit individuals with pediatric expertise to serve as panel members or 
consultants through outreach efforts that will include contacting pediatric professional 
associations, current SGEs, and industry stakeholders.  
 
Appointment of Pediatric Experts 
For SGEs recruited for their pediatric expertise, as with all SGEs, the Centers 
Committee Management will complete the paperwork in accordance with the policies and 
procedures described in the Policy & Guidance Handbook for FDA Advisory 
Committees.  (Although currently being revised, the previous version of this handbook is 
available from National Technical Information Service (NTIS), 5285 Port Royal Rd., 
Springfield, VA 22161, 703-487-4650 (Order No. PB94-158854)) 
 
Team Leader Responsibilities 
The review team leader will determine the need for pediatric expertise during panel 
deliberations by conferring with appropriate individuals in the review division and ODE/ 
OIVD management, as well as with the applicant and advisory panel members.  If the 
team leader concludes that pediatric expertise is appropriate, (s)he will advise the 
executive secretary of the advisory panel that will review the premarket submission or 
regulatory document.   
 
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  Contains Nonbinding Recommendations 
 
Executive Secretary Responsibilities 
The executive secretary will ensure that pediatric expertise is available for the advisory 
panel deliberations.   
 
Quality Control Measures 
The availability of individuals with pediatric expertise will be monitored as a part of 
ODEs and OIVDs Performance Scorecards in the Panel Readiness Index 
measurement. 
 
References 
 
1.  Berhman RE, Kliegman R, Arvin AM, Nelson WE.  Nelson Textbook of 
Pediatrics, 15th Ed.  Philadelphia: W.B. Saunders Company; 1996. 
 
2.  Rudolph AM, et al.  Rudolphs Pediatrics, 21st Ed.  New York: McGraw-Hill; 
2002.  
 
3.  Avery MD, First LR.  Pediatric Medicine, 2nd Ed.  Baltimore: Williams & 
Wilkins; 1994. 
 
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