2006N-0464
  

  
 Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Mr. Mark Rutkiewicz
  

  
Date & Time: 
  

  
12/05/2006 11:12:37
  



  

  
Organization : 
  

  
AGA Medical
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 AGA requests a time to present a methodology to the FDA for managing electronic submissions.  Please contact Mark Rutkiewicz at mrutkiewicz@amplatzer.com for the agenda information.  Mark would request a 30 min time slot.

Mark has worked with the FDA and various companies to create an easy process to create and submit records/submissions to the FDA using off- the-shelf information control tools.  The presentation would include using a business to business model of information sharing and approvals that could be adopted by the FDA.  This methodology would be able to include the use of the XML based submission documents being worked on pharma-side.  The off-the-shelf tool currently uses an XML standard for linking doucments together, this tool is also flexible to include all document format types.