CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—MEDICARE PROGRAM (parts 405 to 426) > PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED > SUBPART B—Medical Services Coverage Decisions That Relate to Health Care Technology (§405.201 to §405.215) > 405.205—Coverage of a non-experimental/investigational (Category B) device.

405.205—Coverage of a non-experimental/investigational (Category B) device.

(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.