[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: 21CFR26.37]

[Page 259]
 
                        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. 26.37   Confidence building activities.

    (a) At the beginning of the transitional period, the Joint Sectoral 
Group will establish a joint confidence building program calculated to 
provide sufficient evidence of the capabilities of the designated 
conformity assessment bodies (CAB's) to perform quality system or 
product evaluations to the specifications of the parties.
    (b) The joint confidence building program should include the 
following actions and activities:
    (1) Seminars designed to inform the parties and CAB's about each 
party's regulatory system, procedures, and requirements;
    (2) Workshops designed to provide the parties with information 
regarding requirements and procedures for the designation and 
surveillance of CAB's;
    (3) Exchange of information about reports prepared during the 
transition period;
    (4) Joint training exercises; and
    (5) Observed inspections.
    (c) During the transition period, any significant problem that is 
identified with a CAB may be the subject of cooperative activities, as 
resources allow and as agreed to by the regulatory authorities, aimed at 
resolving the problem.
    (d) Both parties will exercise good faith efforts to complete the 
confidence building activities as expeditiously as possible to the 
extent that the resources of the parties allow.
    (e) Both the parties will each prepare annual progress reports which 
will describe the confidence building activities undertaken during each 
year of the transition period. The form and content of the reports will 
be determined by the parties through the Joint Sectoral Committee.

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