Lets hope your right champ Rap has worked very hard to get this...

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

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Thorr

63 Posts.

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11/03/20

17:38

Post #: 43432398
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Originally posted by AlCp: ↑

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.

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Lets hope your right champ Rap has worked very hard to get this our results are perfect for the submission fda are clearly picking on every little thing of this product hopefully rap have a update on a plan of attack in regards to this! lets not lose hope but we have failed multiple times but its not the end!
RAP Price at posting: 8.1¢ Sentiment: Hold Disclosure: Held
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Lets hope your right champ Rap has worked very hard to get this...

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