42 CFR 405.205 : Public Health (Part 1 To Parts 1009-1099) — (Subpart A To § 413.355) — Centers For Medicare & Medicaid Services, Department Of Health And Human Services (Subpart A To § 413.355) — Medicare Program (Subpart A To § 413.355) — Federal Health Insurance For The Aged And Disabled (Subpart A To § 405.2472) — Medical Services Coverage Decisions That Relate To Health Care Technology (§ 405.201 To § 405.215) — Coverage of a Category B (Nonexperimental/investigational) 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 Category B (Nonexperimental/investigational).

(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.