[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: 21CFR807.81]

[Page 68]
 
                        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. 807.81  When a premarket notification submission is required.


    (a) Except as provided in paragraph (b) of this section, each person 
who is required to register his establishment pursuant to Sec. 807.20 
must submit a premarket notification submission to the Food and Drug 
Administration at least 90 days before he proposes to begin the 
introduction or delivery for introduction into interstate commerce for 
commercial distribution of a device intended for human use which meets 
any of the following criteria:
    (1) The device is being introduced into commercial distribution for 
the first time; that is, the device is not of the same type as, or is 
not substantially equivalent to, (i) a device in commercial distribution 
before May 28, 1976, or (ii) a device introduced for commercial 
distribution after May 28, 1976, that has subsequently been reclassified 
into class I or II.
    (2) The device is being introduced into commercial distribution for 
the first time by a person required to register, whether or not the 
device meets the criteria in paragraph (a)(1) of this section.
    (3) The device is one that the person currently has in commercial 
distribution or is reintroducing into commercial distribution, but that 
is about to be significantly changed or modified in design, components, 
method of manufacture, or intended use. The following constitute 
significant changes or modifications that require a premarket 
notification:
    (i) A change or modification in the device that could significantly 
affect the safety or effectiveness of the device, e.g., a significant 
change or modification in design, material, chemical composition, energy 
source, or manufacturing process.
    (ii) A major change or modification in the intended use of the 
device.
    (b) A premarket notification under this subpart is not required for 
a device for which a premarket approval application under section 515 of 
the act, or for which a petition to reclassify under section 513(f)(2) 
of the act, is pending before the Food and Drug Administration.
    (c) In addition to complying with the requirements of this part, 
owners or operators of device establishments that manufacture radiation-
emitting electronic products, as defined in Sec. 1000.3 of this chapter, 
shall comply with the reporting requirements of part 1002 of this 
chapter.