[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.36]

[Page 260-261]
 
                        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. 26.36   Listing of CAB's.

    Each party shall designate conformity assessment bodies (CAB's) to 
participate in confidence building activities by transmitting to the 
other party a list of CAB's which meet the criteria for technical 
competence and

[[Page 261]]

independence, as identified in Appendix A of this subpart. The list 
shall be accompanied by supporting evidence. Designated CAB's will be 
listed in Appendix D of this subpart for participation in the confidence 
building activities once confirmed by the importing party. 
Nonconfirmation would have to be justified based on documented evidence.