[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: 21CFR26.69]

[Page 279-280]
 
                        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 C--``Framework'' Provisions
 
Sec. 26.69   Monitoring of conformity assessment bodies.

    The following shall apply with regard to the monitoring of 
conformity assessment bodies (CAB's) listed in subpart B of this part:
    (a) Designating authorities shall assure that their CAB's listed in 
subpart B of this part are capable and remain capable of properly 
assessing conformity of products or processes, as applicable, and as 
covered in subpart B of this part. In this regard, designating 
authorities shall maintain, or cause to maintain, ongoing surveillance 
over their CAB's by means of regular audit or assessment;
    (b) The parties undertake to compare methods used to verify that the 
CAB's listed in subpart B of this part comply with the relevant 
requirements of subpart B of this part. Existing systems for the 
evaluation of CAB's may be used as part of such comparison procedures;
    (c) Designating authorities shall consult as necessary with their 
counterparts, to ensure the maintenance of confidence in conformity 
assessment procedures. With the consent of both

[[Page 280]]

parties, this consultation may include joint participation in audits/
inspections related to conformity assessment activities or other 
assessments of CAB's listed in subpart B of this part; and
    (d) Designating authorities shall consult, as necessary, with the 
relevant regulatory authorities of the other party to ensure that all 
technical requirements are identified and are satisfactorily addressed.