[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR878.4018]

[Page 381]
 
                        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. 878.4018  Hydrophilic wound dressing.

    (a) Identification. A hydrophilic wound dressing is a sterile or 
non-sterile device intended to cover a wound and to absorb exudate. It 
consists of nonresorbable materials with hydrophilic properties that are 
capable of absorbing exudate (e.g., cotton, cotton derivatives, 
alginates, dextran, and rayon). This classification does not include a 
hydrophilic 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]