Miraculins Provides Pre-Submission Documentation to the FDA

Miraculins Inc. (TSXV:MOM) has provided pre-submission documentation to the U.S. Food and Drug Administration on the de novo classification of its Scout® diabetes device. This is the next step towards securing market clearance in the US.

As quoted in the press release:

Based on interactions with the FDA in 2014, including a meeting between a Miraculins delegation and FDA representatives in Washington, D.C., the Company is of the view that there is no predicate device for the Scout®, and that the de novo process could provide the appropriate regulatory pathway for market clearance in the U.S.

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