Recently we have added one "Contraindication" to our IFU of a previously 510(k) cleared device. The FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device" suggest (in the Figure 2, flowchart A, Point A2) to submit a "change being effected (CBE) 510(k)". However, after searching for a while, I have found a very little or no information on the content/structure of a CBE 510(k) notification. It is something new type of submission for us and any information regarding what should be the content of CBE 510(k) would be highly appreciated. Besides "Updated Labeling" what else should be submitted? Does this submission require the submitter to pay the MDUFA Fee?