2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC11
  



  

  

  



  

  
Submitter : 
  

  
Mr. Bruce Boggan
  

  
Date & Time: 
  

  
11/09/2004 02:11:11
  



  

  
Organization : 
  

  
Valley Regional Medical Center
  



  

  
Health Professional
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 While current standards pass the Six Sigma Test, inacting a process that will consume vast resourses, the new Fire Damper test schedule being imposed should pass tests to be a reliable assertion. Anything short will be considered politicaly biased. There is yet to be published tests, testing methodolgy, or scientific evidence to prove the need for increased schedules.