[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: 21CFR26.60]

[Page 276-277]
 
                        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. 26.60   Definitions.


    (a) The following terms and definitions shall apply to this subpart 
only:
    (1) Designating Authority means a body with power to designate, 
monitor, suspend, remove suspension of, or withdraw conformity 
assessment bodies as specified under this part.
    (2) Designation means the identification by a designating authority 
of a conformity assessment body to perform conformity assessment 
procedures under this part.
    (3) Regulatory Authority means a government agency or entity that 
exercises a legal right to control the use or sale of products within a 
party's jurisdiction and may take enforcement action to ensure that 
products marketed within its jurisdiction comply with legal 
requirements.
    (b) Other terms concerning conformity assessment used in this part 
shall have the meaning given elsewhere in this part or in the 
definitions contained in ``Guide 2: Standardization and Related 
Activities--General Vocabulary of the International Organization for 
Standardization (ISO) and the

[[Page 277]]

International Electrotechnical Commission (IEC)'' (ISO/IEC Guide 2) 
(1996 edition), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the 
International Organization for Standardization, 1, rue de Varembe, Case 
postale 56, CH-1211 Geneve 20, Switzerland, or on the Internet at 
``http://www.iso.ch'' or may be examined at the Food and Drug 
Administration's Medical Library, 5600 Fishers Lane, rm. 11B-40, 
Rockville, MD 20857, or the Office of the Federal Register, 800 North 
Capitol St. NW., suite 700, Washington, DC. In the event of an 
inconsistency between the ISO/IEC Guide 2 and definitions in this part, 
the definitions in this part shall prevail.