SPADA Draft Documents

(43) Food and Drug Administration (2014) Guidance for Industry and Food and Drug Administration 1094 Staff: Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based 1095 Diagnostic Devices. Center fo Devices and Radiological Health. Available from: 1096 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocume 1097 nts/UCM327294.pdf , accessed 30 May 2019. 1098 (44) Food and Drug Administration. Premarket Approval (PMA). Available from: 1099 https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premar 1100 ketsubmissions/premarketapprovalpma/ . 1101 (45) Food and Drug Administration. PMA Guidance Documents . Available from: 1102 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Pr 1103 emarketSubmissions/PremarketApprovalPMA/ucm143067.htm , accessed 30 May 2019. 1104

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