i3cglobal

The 510k submission is the second most common pathway for marketing a medical device in the United States. It demonstrates that the device is substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. A 510k Submission document preparation including device testing, and clinical data consolidation takes up almost 4 to 5 months. Post submissions to the FDA generally take up to 6 months, for closing the review queries.