[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: 21CFR860.120]

[Page 181]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 860_MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents
 
                       Subpart C_Reclassification
 
Sec. 860.120  General.


    (a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the act 
provide for reclassification of a device and prescribe the procedures to 
be followed to effect reclassification. The purposes of subpart C are 
to:
    (1) Set forth the requirements as to form and content of petitions 
for reclassification;
    (2) Describe the circumstances in which each of the five statutory 
reclassification provisions applies; and
    (3) Explain the procedure for reclassification prescribed in the 
five statutory reclassification provisions.
    (b) The criteria for determining the proper class for a device are 
set forth in Sec. 860.3(c). The reclassification of any device within a 
generic type of device causes the reclassification of all substantially 
equivalent devices within that generic type. Accordingly, a petition for 
the reclassification of a specific device will be considered a petition 
for reclassification of all substantially equivalent devices within the 
same generic type.
    (c) Any interested person may submit a petition for reclassification 
under section 513(e), 514(b), or 515(b). A manufacturer or importer may 
submit a petition for reclassification under section 513(f) or 520(l). 
The Commissioner may initiate the reclassification of a device 
classified into class III under sections 513(f) and 520(l) of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]

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