A device may not be marketed in the U.S. until the submitter receives a letter finding the device substantially equivalent. If FDA determines that a device is not substantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the De Novo Classification processfile a reclassification petition,
orsubmit a premarket approval application (PMA).
Add to My Watchlist
What is My Watchlist?
