[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.43]

[Page 263-264]
 
                        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. 26.43   Transmission of quality system evaluation reports.

    Quality system evaluation reports covered by Sec. 26.41 concerning 
products covered by this subpart shall be transmitted to the importing 
party within 60-calendar days of a request by the importing party. 
Should a new inspection be requested, the time period shall be extended 
by an additional 30-calendar days. A party may request a new inspection, 
for cause, identified to the other party. If the exporting party cannot 
perform an inspection within a specified period of time, the importing

[[Page 264]]

party may perform an inspection on its own.