[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: 21CFR866.1]

[Page 243]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 866.1  Scope.


    (a) This part sets forth the classification of immunology and 
microbiology devices intended for human use that are in commercial 
distribution.
    (b) The indentification 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, an immunology and microbiology 
device that has two or more types of uses (e.g., used both as a 
diagnostic device and as a microbiology 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 17733, May 11, 1987]

    Effective Date Note: At 68 FR 5827, Feb. 5, 2003, Sec. 866.1 was 
amended by adding paragraph (e), effective May 6, 2003. For the 
convenience of the user, the added text is set forth below.

Sec. 866.1  Scope.

                                * * * * *

    (e) Guidance documents referenced in this part are available on the 
Internet at http:www.fda.gov/cdrh.guidance.html.