[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: 21CFR26.36]
[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. 26.36 Listing of CAB's.
Each party shall designate conformity assessment bodies (CAB's) to
participate in confidence building activities by transmitting to the
other party a list of CAB's which meet the criteria for technical
competence and independence, as identified in Appendix A of this
subpart. The list shall be accompanied by supporting evidence.
Designated CAB's will be listed in Appendix D of this subpart for
participation in the confidence building activities once confirmed by
the importing party. Nonconfirmation would have to be justified based on
documented evidence.
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