2007N-0068
  

  
Medical Device User Fee and Modernization Act: Public Meeting
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  
Submitter : 
  

  
Mr. David Samson
  

  
Date & Time: 
  

  
05/14/2007 07:05:54
  



  

  
Organization : 
  

  
TMJ Concepts
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Please consider the cut-off between large and small companies.  Companies with less than $30,000,000 in annual sales are considered "small". Companies that generate less than $5,000,000 are in the same category and need additional consideration in fee reduction.  They are likely not as capable to afford the same fees as a company generating $30,000,000 and more.  In addition, the agency is proposing additional fees for FDA registered device manufacturers (as we are)as well as fees for filing annual reports (as we do).  The proposed changes will impose additional hardship on companies of our size by stiffling innovation, limiting our ability to subsidize healthcare for employees, and decreasing overall profitability, especially with the ever inflating cost of materials used in our industry.  Please consider fee schedules that are fair to companies that generate much less than $30,000,000.