[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR405.205]

[Page 69]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED--Table of Contents
 
  Subpart B--Medical Services Coverage Decisions That Relate to Health 
                             Care Technology
 
Sec. 405.205  Coverage of a non-experimental/investigational (Category B) device.

    (a) For any device that meets the requirements of the exception at 
Sec. 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 Sec. 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.