[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: 21CFR26.38]

[Page 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. 26.38   Other transition period activities.

    (a) During the transition period, the parties will jointly determine 
the necessary information which must be present in quality system and 
product evaluation reports.
    (b) The parties will jointly develop a notification and alert system 
to be used in case of defects, recalls, and other problems concerning 
product quality that could necessitate additional actions (e.g., 
inspections by the parties of the importing country) or suspension of 
the distribution of the product.