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The Real Issue vs The Real Value, page-45

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longwalker

722 Posts.

151

10/08/17

00:59

Post #: 26403273
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Originally posted by masteryoda ↑

To be frank - blaming the hospital staff doesnt cut it.

For a device to get approved by FDA the device has to prove to no uncertainity its accuracy and capabilities in its application and environment and purpose of use.

This APP is supposed to be used by:
1) The average untrained consumer
2) On any mobile phone
3) The mobile phone could be in any environment
4) Could be affected by infinate interference factors (noise etc..)

At the end of the day, the company can waste money on more stringent trials, with the best clinicians and hospitals, in the perfect acoustically treated rooms etc etc...
And produce the desired clinical outcome (if the algorithm actually works also !)

BUT - the FDA will look at this and go.. that's great. Now produce us the same results with Mum using it at home, or teacher using it at school, Mr RAP, as this is the user group and the method of use, that you are seeking FDA approval for. Otherwise put your algorithm into a hospital grade sound booth and we will give you FDA approval on that piece of equipement.

A likely reality check

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great point raised "intended use" comes with your regulatory approval and has a big impact on how you could commercially use the app......

RAP Price at posting: 7.0¢ Sentiment: None Disclosure: Not Held
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