KALAMAZOO, Mich., April 7, 2017 /PRNewswire/ -- Medizone
International, Inc. (OTCQB: MZEI) announced that in a scheduled conference call late Thursday, April 6,
2017, with representatives of the U.S. Food and Drug Administration ("FDA"), the FDA had advised the Company that they
believed AsepticSure should be classified as a medical device. The FDA representatives recommended that the Company submit
a Premarket Notification ("PMN" or "510(k)") to the FDA and invited Company representatives to schedule follow up meetings to
discuss the best approach for introduction of the AsepticSure technology into the U.S. market. Section 510(k) of the Food,
Drug and Cosmetic Act ("FDCA") requires device manufacturers who must register, to notify FDA of their intent to market a medical
device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to
determine whether the device is equivalent to a device already placed into one of the three classification categories.
Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a
device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to
the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material,
chemical composition, energy source, manufacturing process, or intended use.
In November 2016, Medizone received clearance from the U.S. Environmental Protection Agency
("EPA") (Reg. No. 90607-3) to market AsepticSure ozone disinfectant formula for use for disinfection of non-porous surfaces in
hospitals, clinics, hotels, sporting venues and in the food industry, long-term care facilities, and other critical
infrastructures. However, the FDA has indicated that it also believes it has jurisdiction over AsepticSure as a "medical
device". The Company does not agree with the FDA's position, however the Company has determined to work with its advisors
on a response to the FDA to establish the most efficient route to gain regulatory approval of AsepticSure as a medical device
under the FDCA.
The Company has informed the FDA that it will not market AsepticSure in the US under the previously announced EPA clearance
until it has also obtained 510(k) clearance or other appropriate approvals from the FDA.
Medizone will continue to support commercial operations in markets outside the United States,
which are not affected by this decision. In addition to the EPA clearance, the AsepticSure technology has received market
approval from regulators for use and distribution in Canada, New
Zealand, and Chile, and is currently seeking approvals in other countries in South America, Europe and Asia.
This Press Release may contain certain forward looking statements that could involve substantial risks and uncertainties,
including, but not limited to, the results of ongoing clinical studies, economic conditions, product and technology development,
production efficiencies, product demand, competitive products, competitive environment, successful testing and government
regulatory issues. Additional risks are identified in the company's filings made with the Securities and Exchange
Commission.
Contact:
John Pentony
Investor and Media Relations
Medizone International, Inc.
T: 01 269-202-5020
Email: j.pentony@medizoneint.com
http://www.medizoneint.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/medizone-international-announces-next-steps-on-asepticsure-300436528.html
SOURCE Medizone International, Inc.