I read through all of the 10K reports.
Under the heading “ Recent Developments,” They exposed their successes about Bellville, LaQuinta, Innovation Park, Queens University, the same Patents, over and over again, as well new Patents. They also began to mention EPA and brought up the latest news concerning EPA.
Only twice did they mention FDA. It is noteworthy the phrases used at the end of the Dec 2014 sentence, “ so FDA approval need only be sought when the technology is mature, validated and market-ready. “
It reads as though the FDA made a decision on the LABELING CLASSIFICATION for this device. Since it is a Class 1 Medical Device, it does not really invoke limitations, yet the last line in Dec 2014 indicates APPROVAL comes after the technology is MATURE, VALIDATED AND MARKET-READY.
To me, that does not sound like we have truly obtained undeniable, written, signed, sealed and stamped APPROVAL for AS.
It does mean that once these validation conditions are met, it will be approved without hindrance.
December 2012
In addition, our ozone-based technology should be considered a Class I medical device by the FDA (Code LRJ, Class I Disinfectant, Medical Devices; covered under 880.6890 General Purpose Disinfectants). This is the lowest and safest medical device class. According to FDA 21 CFR Parts 862-892, the technology is exempted from pre-market authorization, so FDA approval need only be sought when the technology is mature, validated and market-ready. The standard FDA Class I device marketing application will apply. As a result, we do not anticipate any FDA-related regulatory issues adversely affecting our products or their use.
December 2014
We anticipate that the United States will become the third country to approve the sale of AsepticSure®. The United States Food and Drug Administration (“FDA”) has ruled that AsepticSure® is a Class I medical device (Code LRJ, Class I Disinfectant, Medical Devices; covered under 880.6890 General Purpose Disinfectants). This is the lowest and safest medical device class. According to FDA 21 CFR Parts 862-892, the technology is exempted from pre-market authorization, so FDA approval need only be sought when the technology is mature, validated and market-ready.
