[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: 21CFR26.39]
[Page 255-256]
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. 26.39 Equivalence assessment.
(a) In the final 6 months of the transition period, the parties
shall proceed
[[Page 256]]
to a joint assessment of the equivalence of the conformity assessment
bodies (CAB's) that participated in the confidence building activities.
CAB's will be determined to be equivalent provided they have
demonstrated proficiency through the submission of a sufficient number
of adequate reports. CAB's may be determined to be equivalent with
regard to the ability to perform any type of quality system or product
evaluation covered by this subpart and with regard to any type of
product covered by this subpart. The parties shall develop a list
contained in Appendix E of this subpart of CAB's determined to be
equivalent, which shall contain a full explanation of the scope of the
equivalency determination, including any appropriate limitations, with
regard to performing any type of quality system or product evaluation.
(b) The parties shall allow CAB's not listed for participation in
this subpart, or listed for participation only as to certain types of
evaluations, to apply for participation in this subpart once the
necessary measures have been taken or sufficient experience has been
gained, in accordance with Sec. 26.46.
(c) Decisions concerning the equivalence of CAB's must be agreed to
by both parties.
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