[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.36]

[Page 255]
 
                        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 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.