Question: Average review times are helpful, but what is the longest (and shortest) review? How are review times distributed through the entire range of review times.
Answer: Very good question! This chart breaks the review times into 30-day increments and shows what percentage of device clearances fell within that timeframe.
While we see a nice curve showing that there are fewer and fewer clearances that fall into the longer review time groups. Good news there. The odd thing is that we have one group that goes against the curve - the 271-300 days group.
If anyone out there has a theory, propose it! We would like to test it and see if we can understand the reason for this artifact.
Question: Beginning in FY 2018, FDA began charging significant user fees for De Novo applications. Has this discouraged submitting De Novo requests?
Answer: Because many De Novo submisstions come from smaller device companies, it seems a reasonable assumption. The user fee went from $0 to $93,229 ($23,307 for small biz).
Based on what is visible in the De Novo data, it looks like the number submitted after the user fee took effect has decreased.
Takes a while for these approvals, so too early to see what is happening in 2019.