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FORM FDA 3514 113 CDRH PREMARKET REVIEW SUBMISSION COVER SHEET Njpa

FORM FDA 3514 113 CDRH PREMARKET REVIEW SUBMISSION COVER SHEET Njpa

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this week we're going to talk about why we need FDA pre submissions the number one resistance I hear from everybody about why we need you know we don't want to do a prub we want to skip the prub it's always about time I don't want to wait 75 days to get the answer so we will address that question first like why what Advantage is there in skipping the Pres submission and going right to a submission and in fact you're not actually doing that what you're doing is you're doing prub testing then your submission if you skip the prub you go right into your testing if you start with testing and you don't have agreement from the FDA in a prub your risk is that you spend tens of thousands of dollars on testing that the FDA might not accept and now you have to repeat it so that's the big risk is that I have to repeat the testing because I did the wrong test either the wrong test the wrong test conditions the wrong acceptance

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