Vivos Inc (RDGL)

[SheikhPenny]

In February 2014 , the FDA rejected the Company's request for marketing clearance for the same device under Section 510(k) of the Act. The FDA determined that the device was not substantially equivalent, concluding that the device is classified by statute as a Class III medical device, unless the device is reclassified.


By filing the de novo submission, the Company is seeking reclassification of the product to Class II. The FDA has 120 days in which to make a decision, though the period will be extended for any time AMIC requires to respond to FDA requests for additional information. If the de novo submission is granted, the device may be immediately marketed in the United States , though the Company would have to secure funding and commercial arrangements before marketing could commence.