21 CFR § 878.4015 - Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

---
identifier: "/us/cfr/t21/s878.4015"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.4015 - Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.4015"
section_name: "Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

(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]