21 CFR 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.
(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.