Medizone International Inc. informed the U.S. FDA that it will not market AsepticSure in the U.S. under previously secured U.S. EPA clearance until it has also obtained 510(k) clearance or other appropriate approvals from the FDA.
The FDA recently advised the company that they believed AsepticSure should be classified as a medical device and recommended that the company submit a premarket notification.
Medizone received clearance from the U.S. EPA to market AsepticSure ozone disinfectant formula for use for disinfection of nonporous surfaces in hospitals, clinics, hotels, sporting venues as well as in the food industry, long-term care facilities and other critical infrastructures, in November 2016.
However, the FDA indicated that it believes it has jurisdiction over AsepticSure as a medical device. The company does not agree with the FDA's position but will work with its advisers on a response to the agency to establish a route to gain regulatory approval of AsepticSure as a medical device.
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 seeking approvals in other countries in South America, Europe and Asia.