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