[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR405.205]



[Page 89]

 

                         TITLE 42--PUBLIC HEALTH

 

                    CHAPTER IV--CENTERS FOR MEDICARE

                          & MEDICAID SERVICES,

                        DEPARTMENT OF HEALTH AND

                             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.