Premarket notification procedure in the USA – part 1.

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) premarket notification to FDA. What is it and why is it required?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device.

However, it is important to understand what the FDA means by a legally marketed device that can be considered equivalent:

  • device that was legally marketed prior to May 28, 1976 (preamendments device)
  • or a device which has been reclassified from Class III to Class II or I
  • a device which has been found SE through the 510(k) process
  • or a device that was granted marketing authorization via the De Novo classification process that is not exempt from premarket notification requirements

A device is substantially equivalent if, in comparison to a predicate it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate.


  • has the same intended use as the predicate; and
  • has different technological characteristics and does not raise different questions of safety and effectiveness; and
  • the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

The MD cannot be placed on the market until the FDA issues a letter of equivalence confirmation.