[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: 21CFR26.63]

[Page 277-278]
 
                        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. 26.63   General coverage of this part.

    (a) This part applies to conformity assessment procedures for 
products and/or processes and to other related cooperative activities as 
described in this part.
    (b) Subparts A and B of this part may include:
    (1) A description of the relevant legislative, regulatory, and 
administrative provisions pertaining to the conformity assessment 
procedures and technical regulations;
    (2) A statement on the product scope and coverage;
    (3) A list of designating authorities;
    (4) A list of agreed conformity assessment bodies (CAB's) or 
authorities or a source from which to obtain a list of such bodies or 
authorities and a statement of the scope of the conformity assessment 
procedures for which each has been agreed;
    (5) The procedures and criteria for designating the CAB's;
    (6) A description of the mutual recognition obligations;
    (7) A sectoral transition arrangement;
    (8) The identity of a sectoral contact point in each party's 
territory; and

[[Page 278]]

    (9) A statement regarding the establishment of a Joint Sectoral 
Committee.
    (c) This part shall not be construed to entail mutual acceptance of 
standards or technical regulations of the parties and, unless otherwise 
specified in subpart A or B of this part, shall not entail the mutual 
recognition of the equivalence of standards or technical regulations.