Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 1 / 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 / § 26.36 Listing of CAB's.
§ 26.36 Listing of CAB's.
Each party shall designate conformity assessment bodies (CAB's) to participate in confidence building activities by transmitting to the other party a list of CAB's which meet the criteria for technical competence and independence, as identified in appendix A of this subpart. The list shall be accompanied by supporting evidence. Designated CAB's will be listed in appendix D of this subpart for participation in the confidence building activities once confirmed by the importing party. Nonconfirmation would have to be justified based on documented evidence.