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.
Title 42 published on 2012-10-01
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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.