Section 405.203 - FDA categorization of investigational devices(a) The FDA assigns a device with an FDA-approved IDE to one of two categories: (1) Category A (Experimental) devices.(2) Category B (Nonexperimental/investigational) devices.(b) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category A (Experimental) or Category B (Nonexperimental).(c) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809 , Dec. 10, 2013