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# FDA Tells Medizone to Use De Novo Pathway for Disinfection Device
- URL: https://www.fdaweb.com/fda-tells-medizone-to-use-de-novo-pathway-for-disinfection-device/
- Published: 2017-08-25T12:00:00.000Z
- Updated: 2026-09-14T22:43:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139474

FDA has told Medizone International that it should proceed to market through the de novo classification pathway for its novel [AsepticSure disinfection system](http://www.medizoneint.com/asepticsure-2/?ref=fdaweb.com). The company says it intends to support its application with data demonstrating AsepticSure’s safety and efficacy profile and low-risk nature.

  
The portable device is intended to be placed in the center of a medical room to be cleaned. “The system is turned on from outside of the room through a remote wireless computer interface,” explains the company. “The room is filled with a unique and patented gas formula that is ozone-based to specific humidity and charge strength. Following the charge period, the disinfection process is remotely turned off and a separate technology is employed that restores the atmosphere inside the room to EPA standards.”