TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

subpart b - SPECIFIC SECTOR PROVISIONS FOR MEDICAL DEVICES

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.