[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.46]

[Page 286]
 
                        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 
 
        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 Sec. Sec. 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 Sec. Sec. 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.