---
kind: "section"
citation: "21 C.F.R. § 878.4015"
title: "21"
number: "878.4015"
heading: "Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive."
url: "https://uscodex.org/cfr/21/878.4015"
---

# §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)](/cfr/21/878.1.md?p=e) for availability of this guidance document.

## Notes

### Amendments

[74 FR 53167, Oct. 16, 2009]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[74 FR 53167, Oct. 16, 2009]