Informational ODE DE NOVOs 2018

Watchcat

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#1
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, and included the remaining 26 direct De novos. 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. However, the dates matched, so I included this De novo in my analysis.

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 This is the longest review time posted for a De novo since the draft guidance was issued on August 14, 2014.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 They may have been declined or “withdrawn,” or they may still be under review.

____________
*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 also come up with my own term for apps.
 
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Watchcat

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#2
I found another glitch or two in the FDA database, a typo (on me), decided I was going off track with the post-NSE reference (since I'm not interested in post-NSE De novos, only direct De novos), and also broke out the number of De novos by reviewing branch. Can't figure out how to edit or delete the original post so...

ODE Direct De novos, 2018

ODE whatevered* a total of 27 direct De novos in 2018.

Review Times

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. However, the dates matched, so I included them in my analysis.

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 870 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.

Reviewing Branches

Direct De novos were reviewed by 9 of ODE’s 12 branches in 2018.

Anesthesiology - 4
Cardiology - 5
Dental - 1
Ear, Nose & Throat - 2
Gastroenterology/Urology - 2
General & Plastic Surgery - 5
General Hospital - 0
Neurology - 4
Ophthalmic - 2
Orthopedic - 0
Physical Medicine - 0
Radiology - 2

ODE Total - 27

________________________
*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 also come up with my own term for apps.
 
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