DRAFT QUESTIONS FOR CLASSIFICATION PANEL

  1.  Are you aware of any other known risks to health presented by the use of the type of device identified by FDA as preamendments reagents for the identification of B. anthracis?

  2.  Are you aware of any additional information, not presented by FDA, which would affect safety and effectiveness of this type of device?  

  3.  Do you believe that general controls are sufficient to provide reasonable assurance of safety and effectiveness of this type of device?  

  4.  If general controls are not sufficient, in your opinion what special control(s) provide reasonable assurance of safety and effectiveness of this type of device?