Replies to post #45486 on Medizone Intl. (fka MZEIQ)

[Tane61]

MZEI fails to gain requested "confirmation" from FDA...

1. Thursday April 6, 2017 teleconference

2. 513(g) submission made on May 17, 2017

• Expected response within 60 days
• Highlights from the submission:
• Request for “confirmation that the company’s AsepticSure® (“AsepticSure® System” or the “system”) is not considered a medical device when used for general hospital disinfection purposes, and in addition, is exempt from premarket notification requirements.”
• Rationale for exemption: “Several devices which have been listed with FDA (class I device with pre-market exemptions) make virtually the same claims as the AsepticSure® system.”

Medizone International prepares plans to submit a marketing application to FDA for use of AsepticSure as a medical device

KALAMAZOO, Mich., Aug. 25, 2017 /PRNewswire/ -- Medizone International, Inc. (OTCQB: MZEI) announced that it has received a written response from the U.S. Food and Drug Administration ("FDA") on the Company's 513(g) submission for disinfection of exposed surfaces and equipment within medical facilities with AsepticSure®. The FDA recommended that the Company proceed to market through the de novo classification pathway given its novel technology compared to other FDA-regulated disinfection systems. Regulation through the de novo pathway requires that the medical device be low- to moderate- risk. The company intends to support its application with data demonstrating AsepticSure's safety and efficacy profile and low risk nature. FDA invited Company representatives to schedule follow up meetings to discuss the best approach for introduction of the AsepticSure technology into the U.S. market. Successfully completing this regulatory pathway would further support the significant competitive advantage of AsepticSure in the marketplace.