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Article: FDA Issues Guidance for Quick-Med Technologies' Exclusive Wound Dressing with pDADMAC.
- Article from:
- Biotech Week
- Article date:
- November 4, 2009
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Quick-Med Technologies, Inc. (OTCBB: QMDT) announced that the Food and Drug Administration has issued Guidance to support the classification of the Company's NIMBUS[R] barrier gauze wound dressings as Class II medical devices. This novel wound dressing received its initial market clearance on February 25, 2009 via 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 Quick-Med Technologies, Inc.).
"This guidance is important because it now lets us pursue other planned medical device applications using our own bandage product as a predicate device" stated ...