Waiting for De Novo approval6 Mar 2024 19:09
FDA Review and Decision for De Novo Application Approval
The FDA reviews the De Novo submission application for completeness and accepts (or rejects) it for substantive review within 15 calendar days. For substantive review, the FDA ultimately evaluates whether the device’s safety and effectiveness “can be assured through the application of general controls or general and special controls” and grants De Novo classification, creating a new device category. This classification creates a new regulatory pathway for other manufacturers to follow, as they can use the 510(k) process to demonstrate substantial equivalence to your device and share its product code.
While the FDA targets 150 calendar days to turnaround a De Novo decision, De Novo reviews can take longer than a 510(k) review as they are considering your submission with no precedent for its safety and effectiveness. If you receive an Additional Information (AI) request from FDA about your De Novo submission, the FDA will pause the clock on your submission’s review time. You must respond to the AI request within 180 calendar days or your submission may be deleted.
I don't suppose that the BOD are required to notify us of any requested (AI) during the process but it could make the process a little longer than the 150 days. It would appear that CIC score kit is effectively in the low to moderate risk category as far as the application is concerned so let's hope the company sail through it without delay and we can see some upward sp price action within the next 6-8 weeks. A successful De Novo application would set a new clear application pathway for our other products using polygenic screening to following in the future so it could be a good positive going forward for GENICODE DYOR and GLA Swissy.
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