Regulations last checked for updates: Nov 24, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024
All TitlesTitle 21Chapter IPart 26Subpart B - Subpart B—Specific Sector Provisions for Medical Devices
View all text of Subpart B [§ 26.31 - § 26.50]
§ 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 §§ 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
source: 63 FR 60141, Nov. 6, 1998, unless otherwise noted.
cite as: 21 CFR 26.46
© 2014 CustomsMobile | Disclaimer | Privacy | About