GREY:CRRVF - Post by User
Post by
buyifisell1on Jun 19, 2019 1:10pm
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Post# 29840620
Statistics on FDA deNovo
Statistics on FDA deNovo
I took a look at the FDA's approvals of deNovo applications this morning. For the 10 approvals issued over the past 3 months, these are the numbers. Not a large sample but better than nothing.
Range: 148 to 573 calendar days.
Mean/median: 298/296 days
Standard deviation: 126 days
It's probably hard to handicap the approval time because there are so many variables. How critical is the device to patients? The application requires evaluation by experts in the field, so does FDA have those experts available to work on the application? Are there topics that the company did not address well in the app and so on?
It seems that we will all have to show patience as the bureaucratic wheels at FDA seem to turn slowly.