Content and Format of a Traditional 510(k)

While there is no set formula for presenting these data, there is a general framework in which to follow. That framework is actually an assemblage of major components that, if all are included and the data presented properly, will help ensure that the application is com­plete. Submitters can make FDA’s task easier by using the new cover sheet 1 15 available from the Center for Devices and Radiological Health (CDRH). Although not required, this cover sheet incorporates a checklist that can help identify the type of submission and whether all pertinent information is included. Other essentials include the following items.