2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  

  



  

  
Submitter : 
  

  
Mr. Ray Leonard
  

  
Date & Time: 
  

  
10/12/2004 02:10:43
  



  

  
Organization : 
  

  
Sunrise Medical
  



  

  
Device Industry
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Dimensions listed as 2 1/3 inches throughout the document should be changed to 2 3/8 inches.  There are no common measuring devices that measure in thirds of an inch, and it (thirds) is not a commonly used dimensional reference.  The dimension is meant to represent 60mm and 2 3/8 inches (2.375') is closer to 60mm (2.362') than 2 1/3 (2.333') is.  The other pertinent dimension in the document is 4 3/4 inches or 120mm.  Half of 4 3/4 inches is 2 3/8 inches.  This change will make the dimensional references more consistent.