[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: 21CFR888.1]

[Page 472]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 888.1  Scope.


    (a) This part sets forth the classification of orthopedic 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.
    (c) To avoid duplicative listings, an orthopedic device that has two 
or more types of uses (e.g., used both as a diagnostic device and as a 
surgical 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.

[52 FR 33702, Sept. 4, 1987, as amended at 68 FR 14137, Mar. 24, 2003]