[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR26.43]
[Page 257]
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
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
party may perform an inspection on its own.
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