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?
Are you aware of any additional information, not
presented by FDA, which would affect safety and effectiveness of this type
of device?
Do you believe that general controls are sufficient to
provide reasonable assurance of safety and effectiveness of this type of
device?
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?