[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: 21CFR864.2220]

[Page 223]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864--HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
               Subpart C--Cell And Tissue Culture Products
 
Sec. 864.2220  Synthetic cell and tissue culture media and components.


    (a) Identification. Synthetic cell and tissue culture media and 
components are substances that are composed entirely of defined 
components (e.g., amino acids, vitamins, inorganic salts) that are 
essential for the survival and development of cell lines of humans and 
other animals. This does not include tissue culture media for human ex 
vivo tissue and cell culture processing applications as described in 
Sec. 876.5885 of this chapter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 864.9.

[45 FR 60583, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 27024, May 16, 2001; 66 FR 38789, July 25, 2001]