SPADA Meeting Book

(42) Food and Drug Adminstration (2005) 510(k) Premarket Notification for JBAIDS Anthrax Detection 1115 System. Available from: 1116 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K051713 , accessed 30 1117 May 2019. 1118 (43) Food and Drug Administration (2014) Guidance for Industry and Food and Drug Administration 1119 Staff: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based 1120 Diagnostic Devices. Center fo Devices and Radiological Health. Available from: 1121 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocume 1122 nts/UCM327294.pdf , accessed 30 May 2019. 1123 (44) Food and Drug Administration. Premarket Approval (PMA). Available from: 1124 https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premar 1125 ketsubmissions/premarketapprovalpma/ . 1126 (45) Food and Drug Administration. PMA Guidance Documents . Available from: 1127 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Pr 1128 emarketSubmissions/PremarketApprovalPMA/ucm143067.htm , accessed 30 May 2019. 1129 (46) JCGM 200:2012 International vocabulary of metrology – Basic and general concepts and 1130 associated terms (VIM) , 3 rd Edition, 1131 https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf , accessed 9 August 1132 2019. 1133

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