[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR860.125]

[Page 182]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 860_MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents
 
                       Subpart C_Reclassification
 
Sec. 860.125  Consultation with panels.

    (a) When the Commissioner is required to refer a reclassification 
petition to a classification panel for its recommendation under Sec. 
860.134, or is required, or chooses, to consult with a panel concerning 
a reclassification petition, such as under Sec. 860.130, Sec. 860.132, 
or Sec. 860.136, the Commissioner will distribute a copy of the 
petition, or its relevant portions, to each panel member and will 
consult with the panel in one of the following ways:
    (1) Consultation by telephone with at least a majority of current 
voting panel members and, when possible, nonvoting panel members;
    (2) Consultation by mail with at least a majority of current voting 
panel members and, when possible, nonvoting panel members; and
    (3) Discussion at a panel meeting.
    (b) The method of consultation chosen by the Commissioner will 
depend upon the importance and complexity of the subject matter involved 
and the time available for action. When time and circumstances permit, 
the Commissioner will consult with a panel through discussion at a panel 
meeting.
    (c) When a petition is submitted under Sec. 860.134 for a post-
enactment, not substantially equivalent device (``new device''), in 
consulting with the panel the Commissioner will obtain a recommendation 
that includes the information described in Sec. 860.84(d). In 
consulting with a panel about a petition submitted under Sec. 860.130, 
Sec. 860.132, or Sec. 860.136, the Commissioner may or may not obtain 
a formal recommendation.