February 28, 2023

FDA 510(k) Change Strategy: Reprocessing-Focused

If the only thing that has changed is the reprocessing process, then the substance of the new 510(k) can just be focused on the aspects that changed.  In other words, no need to restate the device description, software contents, etc., etc., that aren’t affected by the change.  However, each of those various unaffected elements still DOES need to be attended to in their respective sections of the 510(k); yet only by referring FDA to the corresponding details in the prior 510(k) and stating that those elements are unchanged and unaffected for the current subject device.