[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: 21CFR26.67]

[Page 278-279]
 
                        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. 26.67   Suspension of listed conformity assessment bodies.

    The following procedures shall apply with regard to the suspension 
of a conformity assessment body (CAB) listed in subpart B of this part.
    (a) A party shall notify the other party of its contestation of the 
technical competence or compliance of a CAB listed in subpart B of this 
part and the contesting party's intent to suspend such CAB. Such 
contestation shall be exercised when justified in an objective and 
reasoned manner in writing to the other party;
    (b) The CAB shall be given prompt notice by the other party and an 
opportunity to present information in order to refute the contestation 
or to correct the deficiencies which form the basis of the contestation;
    (c) Any such contestation shall be discussed between the parties in 
the Joint Sectoral Committee described in subpart B of this part. If 
there is no Joint Sectoral Committee, the contesting party shall refer 
the matter directly to the Joint Committee. If agreement to suspend is 
reached by the Joint Sectoral Committee or, if there is no Joint 
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
    (d) Where the Joint Sectoral Committee or Joint Committee decides 
that verification of technical competence or compliance is required, it

[[Page 279]]

shall normally be carried out in a timely manner by the party in whose 
territory the body in question is located, but may be carried out 
jointly by the parties in justified cases;
    (e) If the matter has not been resolved by the Joint Sectoral 
Committee within 10 days of the notice of contestation, the matter shall 
be referred to the Joint Committee for a decision. If there is no Joint 
Sectoral Committee, the matter shall be referred directly to the Joint 
Committee. If no decision is reached by the Joint Committee within 10 
days of the referral to it, the CAB shall be suspended upon the request 
of the contesting party;
    (f) Upon the suspension of a CAB listed in subpart B of this part, a 
party is no longer obligated to accept or recognize the results of 
conformity assessment procedures performed by that CAB subsequent to 
suspension. A party shall continue to accept the results of conformity 
assessment procedures performed by that CAB prior to suspension, unless 
a regulatory authority of the party decides otherwise based on health, 
safety or environmental considerations or failure to satisfy other 
requirements within the scope of subpart B of this part; and
    (g) The suspension shall remain in effect until agreement has been 
reached by the parties upon the future status of that body.