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One-Click RI: Medical Devices

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Have an RI question?  Something that is good to know, but takes time (that you don't have!) to analyze?  Send it to us.  We will investigate and post here.
This Week's Question:
Question:  FDA finally changed the definition of "intended uses" in 21 CFR 801.4.  This had been in process since 2017.  Multiple delays for extending the comment periods have come and gone since then.  What was the hold up?  The inclusion of tobacco in the definition brought some controversy. 

You can check out the full FR notice here: 

Answer:  See the redline below for the changes.

21 CFR 801.4 Redline.jpg
Previous Questions:
Question:  Has the addition of a significant user fee for De Novo submissions affected the number of filings?
Answer:  Further digging on De Novos this week.  Easy to see how many were filed in a calendar year, but not as easy to see FDA Fiscal Years.  Looking at the month De Novo filings, we came up with the graph below.  Can you guess when the user fee took effect?  October 1, 2017.  Notice the big surge in submissions in September 2017, just before the user fee was in place.  Interesting to note that 11 of the 15 submitted in September all came in the last week!
What has happened since then?  The numbers have dropped back down to pre-user fee levels.  Best guess at this point is somewhere in the 50-60 range/year.  Again, hard to be exact on this number, because we have no visibility for De Novos that are still under review or have been denied or withdrawn.
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.
510K Trad Dist 2019.png
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?  
DeNovo Numbers 2010-2019-10.png
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. 

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