2006D-0504
  

  
 Guidance for Industry and Food and Drug Administration Staff; Radio-Frequency Wireless Technology in Medical Devices

  


  

  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC2
  



  

  
Submitter : 
  

  
Mr. Edward Karst
  

  
Date & Time: 
  

  
04/02/2007 05:04:52
  



  

  
Organization : 
  

  
Mr. Edward Karst
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 (Section 1) Do not use "him" to describe CDRH's Ombudsman unless you can be certain that FDA will never appoint a woman to that position.



(Section 4 and general) You omitted MICS (Medical Implant Communication Service) from your list of current RF wireless technologies in section 4. It appears nowhere in this document, even though its very purpose is to be used by medical devices. Also, what does the list of "current RF wireless technologies" mean? Are you referring to devices or protocols? Are UHF and VHF omitted because they are not "current"?



(General) Maybe it extends beyond the FDA's purview, but it seems important for device makers to describe what, if anything, they do to conform to the differing wireless standards in different countries. Are there any special consequences caused by taking devices to other countries?



(Appendix A) If you want to enumerate 802.11 standards, you should mention 802.11n since products using it are on the market, even if it hasn't been formally approved.



(Appendix B) The U.S. regulatory agency FCC is called the Federal Communications Commission, not Institute.