21 CFR §26.33

1. (a)There are three components to this subpart each covering a discrete range of products:
   1. (1)Quality System Evaluations. U.S.-type surveillance/postmarket and initial/preapproval inspection reports and European Community (EC)-type quality system evaluation reports will be exchanged with regard to all products regulated under both U.S. and EC law as medical devices.
   2. (2)Product Evaluation. U.S.-type premarket (510(k)) product evaluation reports and EC-type-testing reports will be exchanged only with regard to those products classified under the U.S. system as Class I/Class II-Tier 2 medical devices which are listed in appendix B of this subpart.
   3. (3)Postmarket Vigilance Reports. Postmarket vigilance reports will be exchanged with regard to all products regulated under both U.S. and EC law as medical devices.
2. (b)Additional products and procedures may be made subject to this subpart by agreement of the parties.