[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.50]

[Page 258]
 
                        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.  26.50  Alert system and exchange of postmarket vigilance reports.

    (a) An alert system will be set up during the transition period and 
maintained thereafter by which the parties will notify each other when 
there is an immediate danger to public health. Elements of such a system 
will be described in an Appendix F of this subpart. As part of that 
system, each party shall notify the other party of any confirmed problem 
reports, corrective actions, or recalls. These reports are regarded as 
part of ongoing investigations.
    (b) Contact points will be agreed between both parties to permit 
authorities to be made aware with the appropriate speed in case of 
quality defect, batch recalls, counterfeiting and other problems 
concerning quality, which could necessitate additional controls or 
suspension of the distribution of the product.