21 CFR 878.4015
§ 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 878.4015, § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90406
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.