Article: FDA Issues Guidance for Derma Sciences' Exclusive Wound Dressing With pDADMAC.

Derma Sciences, Inc. (BULLETIN BOARD: DSCI) , a specialty medical device / pharmaceutical company specializing in advanced wound care, announced that the Food and Drug Administration 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 (see also Drug Resistance).

Commenting on the move by the FDA, Derma Sciences CEO ...

Related newspaper, magazine, and journal articles:

 
 
Newsweek Harper's Magazine The Washington Post Chicago Tribune Crain's Chicago Business PRNewswire Pediatric News The Nation Advertising Age The Economist (US) A FREE trial gives you access to over 80 million articles! Access over 6,500 publications with a FREE trial!