definiens: shall mean the standards established by the FDA for current GoodManufacturing Practices, as specified in 21 CFR Section 820 Quality SystemRegulations ; 21CFR Section 807 Establishment Registration and Device Listing forManufacturers of Devices ; 21 CFR Section 803 Medical Device Reporting ; 21CFRSection 801 Labeling ; 21CFR Section 810 Medical Devices Recall Authority ; 21 CFRSection 806 Medical Devices Reports of Corrections and Removals ; the FederalFood, Drug and Cosmetic Act, as amended ; EN46000, 1 and/or 2 ; ISO 9001 and / or9002 ; and the standards established in the European Union 's Council Directive93/42 / EEC of 6/14/93 Concerning Medical Devices ( the )