[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: 21CFR878.1]

[Page 376]
 
                        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 A--General Provisions
 
Sec. 878.1  Scope.


    (a) This part sets forth the classification of general and plastic 
surgery 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 cannot show merely that the 
device is accurately described by the section title and identification 
provision of a regulation in this part, but shall state why the device 
is substantially equivalent to other devices, as required by Sec. 807.87 
of this chapter.
    (c) To avoid duplicative listings, a general and plastic surgery 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a therapeutic device) is listed in one subpart 
only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.
    (e) Guidance documents referenced in this part are available on the 
Internet at http://www.fda.gov/cdrh/guidance.html.

[53 FR 23872, June 24, 1988, as amended at 67 FR 77676, Dec. 19, 2002]