Based on this communication from the FDA, Miraculins plans to continue advancing on the de novo clearance pathway for the Scout® device.
The de novo process is generally considered to be appropriate for “novel” medical devices for which there are no legally marketed predicate devices, and whose risk profiles do not warrant the regulatory pathway known as a premarket approval (PMA), which is required of products considered to have the highest risk to public safety (Class III). The Company is of the view that there is no predicate for the Scout® device, and based on the feedback received from FDA the de novo process could provide the appropriate regulatory pathway for marketing clearance in the U.S.
“Miraculins believes that the communication from the FDA related to a potential de novo classification is a positive and significant development in the regulatory history of the Scout®,” said Christopher Moreau, President and CEO of Miraculins. “Miraculins has been evolving a new regulatory strategy for the Scout® in the U.S. over the last year to focus on the important market of undiagnosed individuals with pre-diabetes where prevention can have the greatest healthcare and economic impact, and as a result of this encouraging FDA guidance the Company will continue to take steps to advance a de novo submission.” In the U.S. it is estimated by the Centers for Disease Control and Prevention in Atlanta that 1 in 3 adults or 86 million people have pre-diabetes (the precursor to type 2 diabetes), yet 9 out 10 are unaware they have the condition.
The de novo process is expected to be less burdensome than would be the case if the Company sought a PMA for the Scout® device. The de novo pre-submission process does not provide a formal determination of regulatory classification nor does it constitute a final determination of the device’s risks and benefits, but rather allows the FDA to review and provide preliminary feedback on the suitability of the de novo classification process for a device, as well as for the planned data to be gathered and submitted by the Company to obtain marketing clearance. A final determination of the device’s safety and effectiveness will be made by FDA once the formal de novo marketing application is submitted.
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