[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: 42CFR405.213]

[Page 70]
 
                         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. 405.213  Re-evaluation of a device categorization.

    (a) General rules. (1) Any sponsor that does not agree with an FDA 
decision that categorizes its device as experimental/investigational 
(Category A) may request re-evaluation of the categorization decision.
    (2) A sponsor may request review by CMS only after the requirements 
of paragraph (b) of this section are met.
    (3) No reviews other than those described in paragraphs (b) and (c) 
of this section are available to the sponsor.
    (4) Neither the FDA original categorization or re-evaluation 
(described in paragraph (b) of this section) nor CMS's review (described 
in paragraph (c) of this section) constitute an initial determination 
for purposes of the Medicare appeals processes under part 405, subpart G 
or subpart H, or parts 417, 473, or 498 of this chapter.
    (b) Request to FDA. A sponsor that does not agree with the FDA's 
categorization of its device may submit a written request to the FDA at 
any time requesting re-evaluation of its original categorization 
decision, together with any information and rationale that it believes 
support recategorization. The FDA notifies both CMS and the sponsor of 
its decision.
    (c) Request to CMS. If the FDA does not agree to recategorize the 
device, the sponsor may seek review from CMS. A device sponsor must 
submit its request in writing to CMS. CMS obtains copies of relevant 
portions of the application, the original categorization decision, and 
supplementary materials. CMS reviews all material submitted by the 
sponsor and the FDA's recommendation. CMS reviews only information in 
the FDA record to determine whether to change the categorization of the 
device. CMS issues a written decision and notifies the sponsor of the 
IDE and the FDA.