[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.66]

[Page 278]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
   PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY--Table of Contents
 
                   Subpart C--``Framework'' Provisions
 
Sec. 26.66   Designation and listing procedures.

    The following procedures shall apply with regard to the designation 
of conformity assessment bodies (CAB's) and the inclusion of such bodies 
in the list of CAB's in subpart B of this part:
    (a) The designating authority identified in subpart B of this part 
shall designate CAB's in accordance with the procedures and criteria set 
forth in subpart B of this part;
    (b) A party proposing to add a CAB to the list of such bodies in 
subpart B of this part shall forward its proposal of one or more 
designated CAB's in writing to the other party with a view to a decision 
by the Joint Committee;
    (c) Within 60 days following receipt of the proposal, the other 
party shall indicate its position regarding either its confirmation or 
its opposition. Upon confirmation, the inclusion in subpart B of this 
part of the proposed CAB or CAB's shall take effect; and
    (d) In the event that the other party contests on the basis of 
documented evidence the technical competence or compliance of a proposed 
CAB, or indicates in writing that it requires an additional 30 days to 
more fully verify such evidence, such CAB shall not be included on the 
list of CAB's in subpart B of this part. In this instance, the Joint 
Committee may decide that the body concerned be verified. After the 
completion of such verification, the proposal to list the CAB in subpart 
B may be resubmitted to the other party.