Here's the jist of the cc.
Form 8-K for IMAGING3 INC
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1-Nov-2010
Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On October 25, 2010, The Company received a letter from the United States Food and Drug Administration (the "FDA"), date stamped October 22, 2010, responding to the Company's application to the FDA for clearance of its 3D medical imaging technology and device. In its application to the FDA under
Section 510(k) of the applicable federal legislation, the Company states that its medical device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976 and therefore should be approved for commercial sale and use as a Class II device, without the necessity for clinical trials. The FDA responded by rejecting the Company's position that its medical device is substantially equivalent to such prior devices. The Company disagrees with the FDA's position and plans to refile its application with additional information supporting the Company's application for clearance. In order to strengthen its next submission to the FDA, the Company may engage an outside independent professional consulting firm having extensive prior experience with the FDA in order to achieve a substantial equivalence determination from the FDA for the Company's medical device and thereby attain its approval for commercial sale and use. While we remain confident of eventually achieving FDA approval of the Company's medical device as a Class II device, there is no assurance that such approval will be obtained or that the Company may not ultimately be required to file it under Class III where clinical trials would be required.
