Ann: Investor Conference Call, page-7

Clearly the FDA has done this so RAP has been informed that it was rejected due to "The probable benefits of the device do not outweigh the probable risks" and not safety and effectiveness.....if RAP explain this more probably tomorrow back to 15c.

Decline

The FDA will decline a De Novo request if we determine that:

• General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device; or
• The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device; or
• The probable benefits of the device do not outweigh the probable risks.

If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. The FDA will issue a written order to the requestor identifying the reasons, which can include lack of performance data that warrant declining the De Novo request. The requester generally should either submit an application for premarket approval under section 515 of the FD&C Act or collect additional information to address the issues and submit a new De Novo request that includes the additional information.