Medizone International, Inc. (OTCMKTS:MZEI) Files An 8-K Other Events

On the afternoon of Thursday, April 6, 2017, Medizone
International, Inc. (Company) representatives participated in a
teleconference with representatives of the U.S. Food and Drug
Administration (FDA). During the conference call, the FDA
representatives advised us that they believed AsepticSure, the
Companys disinfectant system, should be classified as a medical
device under Section 201(h) of the Food, Drug, and Cosmetic Act
of 1938, as amended (FDCA). The FDA representatives recommended
that we consider whether it is appropriate for the Company to
submit a premarket notification to the FDA or to seek pre-market
approval of AsepticSure and invited Company representatives to
schedule follow up meetings in the near future to discuss the
best approach for introduction of the AsepticSure technology into
the U.S. market.

Section 510(k) of the 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, PMN, or 510(k). This notification allows FDA to
determine whether the device is equivalent to a device already
placed into one of the three classification categories. Under FDA
guidelines, a device that reaches market under a 510(k)
notification must be “substantially equivalent” to a device on
the market prior to May 28, 1976 (a “predicate device”). If a
device being submitted is significantly different, relative to a
pre-1976 device, in terms of design, material, chemical
composition, energy source, manufacturing process, or intended
use, the device nominally must go through a premarket approval,
or PMA, although this is not always required. A device that
reaches market via the 510(k) process is not considered to be
“approved” by the FDA. Nevertheless, it can be marketed and
sold in the United States. They are generally referred to as
“cleared” or “510(k) cleared” devices. PMA is the most
stringent type of device marketing application required by FDA.
Under PMA, the maker of the medical device must submit an
application to the FDA and receive approval from the FDA prior to
marketing the device. The PMA application contains information
about how the medical device was designed and how it is
manufactured, as well as preclinical and clinical studies of the
device, demonstrating that it is safe and effective for its
intended use. The expense associated with PMA is generally
greater than 510(k) notification.

In November 2016, we 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
representatives indicated that as a medical device, AsepticSure
would also fall under FDA jurisdiction. We do not agree with the
FDAs position, however the Company has determined to work with
our regulatory 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.

We have informed the FDA that the Company will not market
AsepticSure in the US under the previously announced EPA
clearance until it has also obtained 510(k) clearance or
appropriate approvals from the FDA.

The Company 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.

The Company issued a press release through wire services and
posted a copy of the press release on its website the morning of
April 7, 2017 to disclose the above discussions with the FDA. A
copy of the press release is furnished as Exhibit 99.1 to this
Current Report.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits