21CFR26.32

(a) The provisions of this subpart shall apply to the exchange and, where appropriate, endorsement of the following types of reports from conformity assessment bodies (CAB's) assessed to be equivalent: (b) Appendix A of this subpart names the legislation, regulations, and related procedures under which: (c) For purposes of this subpart, equivalence means that: CAB's in the EC are capable of conducting product and quality systems evaluations against U.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. (1) Under the U.S. system, surveillance/postmarket and initial/preapproval inspection reports; (2) Under the U.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. (1) Products are regulated as medical devices by each party; (2) CAB's are designated and confirmed; and (3) These reports are prepared.