Mr. Robert Thast reports
IZOTROPIC COMPLETES PRE-SUBMISSION MEETING WITH U.S. FDA
Izotropic Corp. has completed its
previously announced
presubmission meeting with the United States FDA (Food and Drug Administration).
The purpose of the meeting was to discuss the company's presubmission application, obtain feedback and confirm next steps. The meeting was attended by Izotropic's management, technical and engineering team members, and its FDA consultant, Matrix Medical Devices.
The meeting allowed Izotropic to clarify its revised
regulatory strategy, which focuses on a broadened intended use and market authorization under the 510(k) pathway.
While further discussion with the agency regarding the details of this regulatory strategy will be required to ensure its viability, the FDA appeared open to the company's new market clearance direction.
As is required and for the purposes of concurrence, Izotropic will submit meeting minutes to the FDA for its review prior to any further disclosure.
We seek Safe Harbor.
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