[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: 21CFR864.1]

[Page 230]
 
                        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 A_General Provisions
 
Sec. 864.1  Scope.


    (a) This part sets forth the classification of hematology and 
pathology devices intended for human use that are in commercial 
distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 may not show merely that the 
device is accurately described by the section title and identification 
provisions of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 
807.87.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.
    (d) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.

[52 FR 17732, May 11, 1987, as amended at 69 FR 12273, Mar. 16, 2004]