CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 878—GENERAL AND PLASTIC SURGERY DEVICES > SUBPART E—Surgical Devices (§878.4010 to §878.5040) > 878.4015—Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

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.

Code of Federal Regulations

[74 FR 53167, Oct. 16, 2009]