[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: 21CFR26.46]

[Page 263]
 
                        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. 26.46   Listing of additional CAB's.

    (a) During the operational period, additional conformity assessment 
bodies (CAB's) will be considered for equivalence using the procedures 
and criteria described in Secs. 26.36, 26.37, and 26.39, taking into 
account the level of confidence gained in the overall regulatory system 
of the other party.
    (b) Once a designating authority considers that such CAB's, having 
undergone the procedures of Secs. 26.36, 26.37, and 26.39, may be 
determined to be equivalent, it will then designate those bodies on an 
annual basis. Such procedures satisfy the procedures of Sec. 26.66(a) 
and (b).
    (c) Following such annual designations, the procedures for 
confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.