[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.39]

[Page 260]
 
                        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. 26.39   Equivalence assessment.

    (a) In the final 6 months of the transition period, the parties 
shall proceed to a joint assessment of the equivalence of the conformity 
assessment bodies (CAB's) that participated in the confidence building 
activities. CAB's will be determined to be equivalent provided they have 
demonstrated proficiency through the submission of a sufficient number 
of adequate reports. CAB's may be determined to be equivalent with 
regard to the ability to perform any type of quality system or product 
evaluation covered by this subpart and with regard to any type of 
product covered by this subpart. The parties shall develop a list 
contained in Appendix E of this subpart of CAB's determined to be 
equivalent, which shall contain a full explanation of the scope of the 
equivalency determination, including any appropriate limitations, with 
regard to performing any type of quality system or product evaluation.
    (b) The parties shall allow CAB's not listed for participation in 
this subpart, or listed for participation only as to certain types of 
evaluations, to apply for participation in this subpart once the 
necessary measures have been taken or sufficient experience has been 
gained, in accordance with Sec. 26.46.
    (c) Decisions concerning the equivalence of CAB's must be agreed to 
by both parties.