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Extra info for Compact regs part 26 : code of federal regulation 21, part 26 : mutual recognition : U.S. and the European community

Example text

B) The joint confidence building program should include the following actions and activities: (1) Seminars designed to inform the parties and CAB’s about each party’s regulatory system, procedures, and requirements; (2) Workshops designed to provide the parties with information regarding requirements and procedures for the designation and surveillance of CAB’s; (3) Exchange of information about reports prepared during the transition period; (4) Joint training exercises; and (5) Observed inspections.

3. Commencement of the Operational Period a. At the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period. b. FDA will expand the program to categories of Class II devices as is consistent with the results of the pilot, and with FDA’s ability to write guidance documents if the device pilot for the third party review of medical devices is successful. The MRA will cover to the maximum extent feasible all Class II devices listed in Table 3 for which FDA-accredited third party review is available in the United States.

Should a new inspection be requested, the time 41 period shall be extended by an additional 30calendar days. A party may request a new inspection, for cause, identified to the other party. If the exporting party cannot perform an inspection within a specified period of time, the importing party may perform an inspection on its own. 44 Transmission of product evaluation reports. Transmission of product evaluation reports will take place according to the importing party’s specified procedures. 45 Monitoring continued equivalence.

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