[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: 21CFR26.35]
[Page 255]
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. 26.35 Length and purpose of transition period.
There will be a 3-year transition period immediately following the
date described in Sec. 26.80(a). During the transition period, the
parties will engage in confidence-building activities for the purpose of
obtaining sufficient evidence to make determinations concerning the
equivalence of conformity assessment bodies (CAB's) of the other party
with respect to the ability to perform quality system and product
evaluations or other reviews resulting in reports to be exchanged under
this subpart.
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