The premarket notification [510(k)] is the most common
pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements.
The
510(k) premarket submission is made to the US FDA to demonstrate that the subject
device to be marketed is substantially equivalent (as least as
safe and effective) to a legally marketed device (predicate device).
A 510(k) must demonstrate that a proposed product is
substantially equivalent to another, legally marketed medical device
that is also lower-risk and is not subject to premarket approval (PMA).