1. (a) For any device that meets the requirements of the exception at § 411.15(o) of this chapter, the following procedures apply:

   1. (1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as Category B (Nonexperimental/investigational).
   2. (2) CMS uses the categorization of the device as a factor in making Medicare coverage decisions.
2. (b) If the FDA becomes aware that a categorized device no longer meets the requirements of the exception at § 411.15(o) of this chapter, the FDA notifies the sponsor and CMS and the procedures described in paragraph (a)(2) of this section apply.

[60 FR 48423, Sept. 19, 1995, as amended at 78 FR 74809, Dec. 10, 2013