[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: 21CFR807.85]

[Page 68-69]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
              Subpart E--Premarket Notification Procedures
 
Sec. 807.85  Exemption from premarket notification.

    (a) A device is exempt from the premarket notification requirements 
of this subpart if the device intended for introduction into commercial 
distribution is not generally available in finished form for purchase 
and is not offered through labeling or advertising by the manufacturer, 
importer, or distributor thereof for commercial distribution, and the 
device meets one of the following conditions:
    (1) It is intended for use by a patient named in the order of the 
physician or dentist (or other specially qualified person); or
    (2) It is intended solely for use by a physician or dentist (or 
other specially qualified person) and is not generally available to, or 
generally used by, other physicians or dentists (or other specially 
qualified persons).
    (b) A distributor who places a device into commercial distribution 
for the first time under his own name and a repackager who places his 
own name on a device and does not change any other labeling or otherwise 
affect the device shall be exempted from the premarket notification 
requirements of this subpart if:
    (1) The device was in commercial distribution before May 28, 1976; 
or

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    (2) A premarket notification submission was filed by another person.