Office of In Vitro Diagnostic and Radiological Health (OIR) De novos 2018

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OIR whatevered* a total of 14 direct De novos in 2018.

Reviewing Branches

In 2018, direct De novos were reviewed by 6 of OIR’s 7 branches.

Reviewing Branch
Immunology - 1
Microbiology - 4
Clinical Chemistry - 4
Pathology - 1
Toxicology - 2
Hematology - 0
Radiology - 2
OIR Total - 14


Review Times

In Vitro Diagnostics

Two of the Received Dates in the Reclassification Order were different from those listed in the De novo database. For one De novo, the difference was only one day; I used the date in the Reclassification Order. For the other De novo, the Received Dates differed by over 8 months. The database indicated that the original submission was by the company; the Reclassification Order was addressed to an attorney. I used the date in the database.

The average time from the date of receipt listed in the Reclassification Order to the date of the Reclassification Order, was 274 days. The shortest review time was 109 days (a little over 3.5 months) for a real time, continuous glucose monitoring device. The longest review took 488 days (one year four months) for an IVD used for direct detection of cytomegalovirus (CMV) DNA in saliva samples from neonates younger than 21 days of age.

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 They may have been declined or “withdrawn,” or they may still be under review.

Radiology Devices

The two radiology De novos took 108 and 137 days to 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.”
 
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