fects 9 21 U.S.C. 355(d) 10 See the guidance for industry and Food and Mug Administration staff In Vitro Companion Diagnostic Devices available on the Guidance Documents (Medical Devices and Radiation-Emitting Products) Web page at http://www.fda.goviMedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. 4 EFTA_R1_00015162 EFTA01734948 Conta