[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.31]

[Page 259-260]
 
                        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. 26.31   Purpose.


    (a) The purpose of this subpart is to specify the conditions under 
which a party will accept the results of quality system-related 
evaluations and inspections and premarket evaluations of the

[[Page 260]]

other party with regard to medical devices as conducted by listed 
conformity assessment bodies (CAB's) and to provide for other related 
cooperative activities.
    (b) This subpart is intended to evolve as programs and policies of 
the parties evolve. The parties will review this subpart periodically, 
in order to assess progress and identify potential enhancements to this 
subpart as Food and Drug Administration (FDA) and European Community 
(EC) policies evolve over time.