[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: 21CFR26.35]

[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.  26.35  Length and purpose of transition period.

    There will be a 3-year transition period immediately following the 
date described in Sec.  26.80(a). During the transition period, the 
parties will engage in confidence-building activities for the purpose of 
obtaining sufficient evidence to make determinations concerning the 
equivalence of conformity assessment bodies (CAB's) of the other party 
with respect to the ability to perform quality system and product 
evaluations or other reviews resulting in reports to be exchanged under 
this subpart.