[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5440]

[Page 416]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 880_GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
     Subpart F_General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5440  Intravascular administration set.

    (a) Identification. An intravascular administration set is a device 
used to administer fluids from a container to a patient's vascular 
system through a needle or catheter inserted into a vein. The device may 
include the needle or catheter, tubing, a flow regulator, a drip 
chamber, an infusion line filter, an I.V. set stopcock, fluid delivery 
tubing, connectors between parts of the set, a side tube with a cap to 
serve as an injection site, and a hollow spike to penetrate and connect 
the tubing to an I.V. bag or other infusion fluid container.
    (b) Classification. Class II (special controls). The special control 
for pharmacy compounding systems within this classification is the FDA 
guidance document entitled ``Class II Special Controls Guidance 
Document: Pharmacy Compounding Systems; Final Guidance for Industry and 
FDA Reviewers.'' Pharmacy compounding systems classified within the 
intravascular administration set are exempt from the premarket 
notification procedures in subpart E of this part and subject to the 
limitations in Sec. 880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 15798, Mar. 21, 
2001]