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

Sample text

S. system, premarket (510(k)) product evaluation reports; (3) Under the European Community (EC) system, quality system evaluation reports; and (4) Under the EC system, EC type examination and verification reports. (b) Appendix A of this subpart names the legislation, regulations, and related procedures under which: (1) Products are regulated as medical devices by each party; (2) CAB’s are designated and confirmed; and (3) These reports are prepared. S. regulatory requirements in a manner equivalent to those conducted by FDA; and CAB’s in the United States are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CAB’s.

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.

A) At the beginning of the transitional period, the Joint Sectoral Group will establish a joint confidence building program calculated to provide sufficient evidence of the capabilities of the designated conformity assessment bodies (CAB’s) to perform quality system or product evaluations to the specifications of the parties. (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.

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