ODE whatevered* a total of 28 De novos in 2018.
Two of the 28 De novos were post-NSE, including one originally submitted by the CDC in 2007. I excluded these two De novos from my analysis, since I'm interested only in direct De novos, and included the remaining 26 in my analysis. The Received Dates in the Reclassification Order were sometimes different from those listed in the De novo database. I used the dates in the Reclassification Orders.
The regulation number and product code listed in the database for one De novo did not match those in the reclassification order and decision summary. Before I finalized my analysis, I confirmed the correct regulation number and product code with the reviewing branch.
The average time from the date of receipt listed in the Reclassification Order to the date of the Reclassification Order, was 359 days.
This seems like an encouraging improvement over the average review time of 401 days in 2017, but some of this difference is undoubtedly due to the review of two mobile medical appsies* in 2018. Both were both designated Class I 510(k) exempt and were reviewed in 28 and 33 days, by far the shortest review times for a direct De novo so far. No De novos for mobile medical appsies were whatevered in 2017.
The longest review took 820 days, or just under 2.5 years, for a percutaneous catheter system used to create an arteriovenous fistula hemodialysis patients. This is the longest review time posted for a De novo since the draft guidance was issued on August 14, 2014.
Much longer review times may yet be posted. At least half of the De novos submitted between August 15, 2014 and December 31, 2014, have yet to be accounted for. Due to a lack of transparency and accountability in the CDRH premarket review process, the status of these De novos is unknown. They may have been declined or "withdrawn," or they may still be under review.
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*I'm permanently declining to describe the outcome of a De novo review as either "classified" or "granted." I will instead be using some form of the verb "whatever." I've come up with my own term for apps.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------