Overview: This webinar is intended to demonstrate how to prepare a 510(k) in an adequate manner with increased quality to expedite the streamlined review process. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices.
Pursuant to the section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), the 510(k) premarket submission is made to 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).
Pursuant to the section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), the 510(k) premarket submission is made to 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).
