Replies to post #37218 on Medizone Intl. (fka MZEIQ)

[GreenOwner]

Regulatory Affairs – USA

A regulatory decision has been received from the United States FDA. In keeping with the expectations of our regulatory team, the FDA has ruled that AsepticSure will be classified as a Class 1 medical device for sales in the US. The FDA Class 1 ruling has straightforward requirements we are now in the process of meeting. Final regulatory approvals for the US market by both the FDA and EPA should be achieved not later than January 2013.

Obviously, they were off by 2 years with that statement.

[Eli's Gone]

According to the company---and I am assuming this is based on information from the FDA---as a Class 1 Exempt device, Asepticsure will only need to be registered with the FDA and labeled-requiring no premarket 510(k) FDA review...

http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194468.htm