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:
Under the U.S. system, surveillance/postmarket and initial/preapproval inspection reports;
Under the U.S. system, premarket (510(k)) product evaluation reports;
Under the European Community (EC) system, quality system evaluation reports; and
Under the EC system, EC type examination and verification reports.
Appendix A of this subpart names the legislation, regulations, and related procedures under which:
Products are regulated as medical devices by each party;
CAB's are designated and confirmed; and
These reports are prepared.
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.
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