[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: 21CFR26.46]
[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. 26.46 Listing of additional CAB's.
(a) During the operational period, additional conformity assessment
bodies (CAB's) will be considered for equivalence using the procedures
and criteria described in Sec. Sec. 26.36, 26.37, and 26.39, taking
into account the level of confidence gained in the overall regulatory
system of the other party.
(b) Once a designating authority considers that such CAB's, having
undergone the procedures of Sec. Sec. 26.36, 26.37, and 26.39, may be
determined to be equivalent, it will then designate those bodies on an
annual basis. Such procedures satisfy the procedures of Sec. 26.66(a)
and (b).
(c) Following such annual designations, the procedures for
confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.
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