[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: 21CFR26.40]

[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. 26.40   Start of the operational period.

    (a) The operational period will start at the end of the transition 
period after the parties have developed the list of conformity 
assessment bodies (CAB's)

[[Page 262]]

found to be equivalent. The provisions of Secs. 26.40, 26.41, 26.42, 
26.43, 26.44, 26.45, and 26.46 will apply only with regard to listed 
CAB's and only to the extent of any specifications and limitations 
contained on the list with regard to a CAB.
    (b) The operational period will apply to quality system evaluation 
reports and product evaluation reports generated by CAB's listed in 
accordance with this subpart for the evaluations performed in the 
respective territories of the parties, except if the parties agree 
otherwise.