2004N-0254 - Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children; Request for Comments

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  

  



  

  
Submitter : 
  

  
Mr. Richard Podell
  

  
Date & Time: 
  

  
07/26/2004 04:07:53
  



  

  
Organization : 
  

  
Management Advisory Services
  



  

  
Device Industry
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Small size of pediatric device market would require economic incentive to device developers, such as orphan drug incentives.



Reluctance to expose younger patients to clinical trial risks requires even more stringent guidelines for IDE and more comprehensive education for parent/guardian, including issues relating to informed consent.