2006N-0362
  

  
 General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC1
  



  

  
Submitter : 
  

  
Dr. Jeffrey Lawson
  

  
Date & Time: 
  

  
01/29/2007 08:01:42
  



  

  
Organization : 
  

  
Duke University
  



  

  
Category : 
  

  
Academia
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 January 27, 2007



Division of Dockets Management (HFA-305) 

Food and Drug Administration, 

5630 Fishers Lane, 

Rm. 1061, 

Rockville, MD 20852





Ref:  Comments on the Reclassification Proposal and Draft Special Controls Guidance Document for Absorbable Hemostats (Dockets 2006N-0362 and 2006D-0363)





As conference convener and on behalf of the conference participants, I am submitting a summary of the Absorbable Hemostat Consensus Conference entitled Regulation of Absorbable Hemostatic Agents: Guidance for Encouraging Innovation Without Compromising Patient Safety.



Please consider these in reference to the above referenced dockets and thank you for the opportunity to comment on this important matter.  I would be happy to discuss this summary report with the FDA panel should any clarification be needed.





Sincerely,  









Jeffrey H. Lawson, M.D., Ph.D.

Associate Professor of Surgery

Assistant Professor of Pathology

Duke University Medical Center

Durham, North Carolina



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2006N-0362-EC1-Attach-1.PDF