[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR890.1]

[Page 487]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 890--PHYSICAL MEDICINE DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 890.1  Scope.


    (a) This part sets forth the classification of physical medicine 
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) To avoid duplicative listings, a physical medicine device that 
has two or more types of uses (e.g., used both as a diagnostic device 
and as a therapeutic device) is listed only in one subpart.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.

[52 FR 17741, May 11, 1987]