42 C.F.R. § 405.205 Coverage of a non-experimental/investigational (Category B) device.
Title 42 - Public Health
(a) For any device that meets the requirements of the exception at §411.15(o) of this chapter, the following procedures apply: (1) The FDA notifies CMS, when it notifies the sponsor, that the device is categorized by FDA as non-experimental/investigational (Category B). (2) CMS uses the categorization of the device as a factor in making Medicare coverage decisions. (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.
Title 42: Public Health
PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
Subpart B—Medical Services Coverage Decisions That Relate to Health Care Technology
§ 405.205 Coverage of a non-experimental/investigational (Category B) device.
