[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: 21CFR26.47]

[Page 261-262]
 
                        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 B--Specific Sector Provisions for Medical Devices
 
Sec. 26.47   Role and composition of the Joint Sectoral Committee.

    (a) The Joint Sectoral Committee for this subpart is set up to 
monitor the activities under both the transitional and operational 
phases of this subpart.
    (b) The Joint Sectoral Committee will be cochaired by a 
representative of the Food and Drug Administration (FDA) for the United 
States and a representative of the European Community (EC) who will each 
have one vote. Decisions will be taken by unanimous consent.
    (c) The Joint Sectoral Committee's functions will include:
    (1) Making a joint assessment of the equivalence of conformity 
assessment bodies (CAB's);
    (2) Developing and maintaining the list of equivalent CAB's, 
including any limitation in terms of their scope of activities and 
communicating the list

[[Page 262]]

to all authorities and the Joint Committee described in subpart C of 
this part;
    (3) Providing a forum to discuss issues relating to this subpart, 
including concerns that a CAB may no longer be equivalent and 
opportunity to review product coverage; and
    (4) Consideration of the issue of suspension.