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DE NOVO SUMMARY - IVDs and Radiology Devices, 2015-2018

Watchcat

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#1
I'm attaching a summary of the data I've crunched for IVD and radiology De novos that were whatevered 2015-2018. I have looked mostly at review times. I also include some data on 510(k)s supported by clinical trials and PMAs for comparison.

Please take these data with a shaker of salt. I've checked and rechecked the figures, but it's an onerous task, prone to error. The dates in CDRH's database sometimes conflict with the dates in the letters. Above all, the De novos are too few and the devices too diverse for averages to mean much. Maybe someday. In the interim, just a little snack for the data geeks among us.
 
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Watchcat

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#2
Just a heads up that I have replaced the attachment with a corrected version. I wrote 510(k) instead of PMA twice in the section on MDUFA fees.
 
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