[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: 21CFR807.100]

[Page 73-74]
 
                        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. 807.100  FDA action on a premarket notification.

    (a) After review of a premarket notification, FDA will:
    (1) Issue an order declaring the device to be substantially 
equivalent to a legally marketed predicate device;
    (2) Issue an order declaring the device to be not substantially 
equivalent to any legally marketed predicate device;
    (3) Request additional information; or
    (4) Withhold the decision until a certification or disclosure 
statement is submitted to FDA under part 54 of this chapter.
    (5) Advise the applicant that the premarket notification is not 
required. Until the applicant receives an order declaring a device 
substantially equivalent, the applicant may not proceed to market the 
device.

[[Page 74]]

    (b) FDA will determine that a device is substantially equivalent to 
a predicate device using the following criteria:
    (1) The device has the same intended use as the predicate device; 
and
    (2) The device:
    (i) Has the same technological characteristics as the predicate 
device; or
    (ii)(A) Has different technological characteristics, such as a 
significant change in the materials, design, energy source, or other 
features of the device from those of the predicate device;
    (B) The data submitted establishes that the device is substantially 
equivalent to the predicate device and contains information, including 
clinical data if deemed necessary by the Commissioner, that demonstrates 
that the device is as safe and as effective as a legally marketed 
device; and
    (C) Does not raise different questions of safety and effectiveness 
than the predicate device.
    (3) The predicate device has not been removed from the market at the 
initiative of the Commissioner of Food and Drugs or has not been 
determined to be misbranded or adulterated by a judicial order.

[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]