Miraculins Reports Supplemental Filing to USFDA for De Novo Pre-Submission

Miraculins Inc. (TSXV:MOM) reported that as part of its ongoing dialogue with the United States Food and Drug Administration, the Company has made a supplemental filing regarding its recent de novo pre-submission for its Scout® device.
As quoted in the press release:

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 it has received from the FDA to date, the de novo process could provide the appropriate regulatory pathway for marketing clearance in the U.S.
The Company will update the market as appropriate regarding its ongoing regulatory discussions with the FDA as they continue to unfold.

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