[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: 42CFR405.213]



[Page 89-90]

 

                         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. 405.213  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.



[[Page 90]]



    (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.