Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

21 C.F.R. § 878.4015
in effectEffective: 2024-07-01
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(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.

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