Regulation Text
(a) During the operational period, additional conformity assessment bodies (CAB's) will be considered for equivalence using the procedures and criteria described in §§ 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 §§ 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 § 26.66(a) and (b) .
(c) Following such annual designations, the procedures for confirmation of CAB's under § 26.66(c) and (d) shall apply.
Authority
5 U.S.C. 552;15 U.S.C. 1453,1454,1455;18 U.S.C. 1905;21 U.S.C. 321,331,351,352,355,360,360b,360c,360d,360e,360f,360g,360h,360i,360j,360l,360m,371,374,381,382,383,393;42 U.S.C. 216,241,242l,262,264,265.