[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4020]

[Page 367]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 878.4020  Occlusive wound dressing.

    (a) Identification. An occlusive wound dressing is a nonresorbable, 
sterile or non-sterile device intended to cover a wound, to provide or 
support a moist wound environment, and to allow the exchange of gases 
such as oxygen and water vapor through the device. It consists of a 
piece of synthetic polymeric material, such as polyurethane, with or 
without an adhesive backing. This classification does not include an 
occlusive wound dressing that contains added drugs such as antimicrobial 
agents, added biologics such as growth factors, or is composed of 
materials derived from animal sources.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in part 807, subpart E of 
this chapter subject to the limitations in Sec. 878.9.

[64 FR 53929, Oct. 5, 1999]