Medizone said last Friday after meeting with the FDA that it will pursue 510(k) clearance for its AsepticSure portable hospital disinfection system.
The system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere in the room and restores it to within EPA standards, according to the company’s website.
The Kalamazoo, Mich.-based company said it won clearance from the US Environmental Protection Agency last November to market the AsepticSure ozone disinfectant formula for use in disinfecting non-porous surfaces in hospitals, clinics, hotels and various other venues. The FDA later asserted that it believes it has jurisdiction over the AsepticSure as a medical device.
Medizone said it “does not agree with the FDA’s position” but that it “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,” according to a press release.
The group said it notified the FDA that it will not market the AsepticSure in the US under its previous EPA clearance until it has also obtained 510(k) clearance or other appropriate approval.
The company said it will continue to support commercial operations outside the US, which are not affected by the decision.