Replies to post #42478 on Medizone Intl. (fka MZEIQ)

[GreenOwner]

I read this as having the ability to use it for the trials.
Once the Trials prove effective and safe, FDA will likely grant their approval.


We anticipate that the United States will become the third country approving the sale of AsepticSure®. As expected by our development and regulatory team, 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.

Interaction with both the FDA and Environmental Protection Agency (“EPA”) in the United States has progressed well and we currently anticipate obtaining approval for sale into the United States market early in 2014. The EPA allows the use of ozone with no reporting or record keeping requirements. The FDA approved ozone in bottled water in 1982 and granted a petition for use with fruits, vegetables, meat and poultry in June 2000. The U.S. Department of Agriculture (“USDA”) approved ozone as organic under the USDA Organic Rule in 2000.

In certain applications, ozone may be considered a pesticide used for decontamination (as would be the case in anti- terrorism applications). In that event, submission of safety and effectiveness data may be required. The precedent technology is vaporized hydrogen peroxide. The EPA may be most interested in bactericidal and sporicidal activity and ozone destruction and residual ozone levels. According to our data, residual ozone levels achieved are a safe level of <0.02 ppm. As a result, we do not anticipate any EPA-related regulatory issues.

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So everyone is partially right. But Full Approval has not been achieved.....yet.

[never-say-die]

It is clear from what Ed said here that they do not have FDA approval to sell in the USA, only the ability to conduct premarket testing on US soil. They must then submit the test findings to the FDA for approval. Based on past experience, I'll be really surprised if this process moves along swiftly and goes smoothly.