[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: 21CFR807.97]

[Page 73]
 
                        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. 807.97  Misbranding by reference to premarket notification.

    Submission of a premarket notification in accordance with this 
subpart, and a subsequent determination by the Commissioner that the 
device intended for introduction into commercial distribution is 
substantially equivalent to a device in commercial distribution before 
May 28, 1976, or is substantially equivalent to a device introduced into 
commercial distribution after May 28, 1976, that has subsequently been 
reclassified into class I or II, does not in any way denote official 
approval of the device. Any representation that creates an impression of 
official approval of a device because of complying with the premarket 
notification regulations is misleading and constitutes misbranding.