[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: 42CFR405.203]



[Page 88]

 

                         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. 405.203  FDA categorization of investigational devices.



    (a) The FDA assigns a device with an FDA-approved IDE to one of two 

categories:

    (1) Experimental/Investigational (Category A) Devices.

    (2) Non-Experimental/Investigational (Category B) Devices.

    (b) The FDA notifies CMS, when it notifies the sponsor, that the 

device is categorized by FDA as experimental/investigational (Category 

A) or non-experimental/investigational (Category B).

    (c) CMS uses the categorization of the device as a factor in making 

Medicare coverage decisions.



[[Page 89]]