Derma Sciences, Inc. (Princeton, NJ), a specialty medical device/pharmaceutical company specializing in advanced wound care, recently announced that the US Food and Drug Administration (FDA) has issued its Guidance Document to support the classification of the company's BIOGUARD™ barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009, via the FDA's de novo review process, a special clearance program for medical devices that are found to be "not substantially equivalent" to any predicate device.

The newly issued guidance pertains to a wound dressing with permanently bound cationic biocide polyDADMAC, one of the molecular entities covered in nine Quick-Med US patents/patents pending and in 24 foreign counterparts.

Visit www. www.dermasciences.com for more information.