§ 878.4015. Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
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/us/cfr/t21/s§ 878.4015·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.
(b)Classification. Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document. [74 FR 53167, Oct. 16, 2009]