2006D-0347
  

  
 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC37
  



  

  
Submitter : 
  

  
Dr. Franklin Cockerill, III
  

  
Date & Time: 
  

  
03/07/2007 06:03:46
  



  

  
Organization : 
  

  
Mayo Clinic Rochester
  



  

  
Category : 
  

  
Consumer Group
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Mayo Clinic Rochester is pleased to have the opportunity to comment on the Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays document.  We believe that additional information is required to clarify specific elements in the guidance. 

1) Initially it may be difficult for a laboratory to determine if its test systems fall within the definition of an IVDMIA which may result in under submission. Consider issuing a companion document with specific examples of test systems that fall within the definition of an IVDMIA; include specific reasons that qualify the test system as an IVDMIA.  In addition, it would be very helpful to have examples of test systems that are exempt with an explanation of why the test system is exempt.

2) Implementation and execution of these requirements will take significant resources on the part of both the laboratory industry and the FDA. Will criteria be established for which test systems will be required to be submitted first?  What will be the timeline for submitting test systems that are already in use?  Should a facility plan to submit all test systems that meet the definition of IVDMIA or is FDA planning to grandfather in test systems that have been in use for several years?  Does FDA have the staffing to review these submissions in a timely manner? 

3) Will industry be required to submit supplements to the initial application if changes are made to the test system?  Please define the submission process and provide specific examples of when a supplement will be required?

4) FDA field investigators expect industry to produce documented evidence of any communications we have with CDRH staff, specifically if that communication is determining if a specific product does or does not fall within a specific regulation.  Please describe how FDA plans to address inquiries from industry on determining the specific classification of a test system developed by a laboratory.       

5) CMS regulates the laboratory industry quite differently than FDA regulates the medical device industry.  How does FDA plan to educate laboratories on the medical device requirements specifically relating this guidance back to the regulations?        

Thank you for your consideration of our comments in formulating the final requirements.