Published on September 14, 2009 at 7:18 AM
Noveko International Inc. ("the Company") is pleased to announce that further to its request, the Food and Drugs Administration (the "FDA") accepted to meet with the Company, to consider an additional labelling claim for its Noveko(TM) masks and respirators. At a formal pre-IDE (investigational device exemption) meeting with the FDA held earlier this week, both parties held discussions with respect to this additional claim which would allow the Noveko(TM) masks and respirators to be marketed as a medical device reducing exposure to airborne influenza particles.
Dialogue is continuing with the FDA in order for the Company to obtain clarifications and guidelines for providing the supportive data for a future submission by the Company to market in the US its Noveko(TM) masks and respirators with an antiviral claim.
Simultaneously, the process is continuing regarding the current pending 510(k) submission for the Noveko(TM) 3xEZ Antibacterial Surgical Mask.
Source: NOVEKO INTERNATIONAL INC.