Ann: Update on US FDA De Novo Classification Request, page-202

Thanks Red for your comments - informative as always but I am not sure about the Additional Information required? - was that not asked for in the initial discussions and if not what could it possibly be.

To say it is Risk based is interesting - Risk is defined as Probability against Consequence
- Consequence in America is high but this is the same for all devices - and our probability of success is high - equal to and above the gold standard.

I feel this additional information needs to be spelt out - it may not be as bad as first thought

Roy Boy