SPADA Docs

(39) Food and Drug Adminstration, How to Submit a Pre-EUA for In vitro Diagnostics. 1164 Available from: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal- 1165 regulatory-and-policy-framework/how-submit-pre-eua-vitro-diagnostics-fda , accessed 30 1166 May 2019. 1167 (40) Food and Drug Administration (2019) Guidance for Industry and Food and Drug 1168 Administration Staff: Requests for Feedback and Meetings for Medical Device 1169 Submissions: The Q-Submission Program. Center for Devices and Radiological Health. 1170 Available from: 1171 https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedoc 1172 uments/ucm311176.pdf , accessed 30 May 2019. 1173 (41) Food and Drug Adminstration., Available from: 1174 https://www.fda.gov/downloads/medicaldevices/.../ucm284443.pdf . 1175 (42) Food and Drug Adminstration (2017) Guidance for Industry and Food and Drug 1176 Administration Staff: FDA and Industry Actions on Premarket Notification (510(k)) 1177 Submissions: Effect on FDA Review Clock and Goals. Center for Devices and Radiological 1178 Health. Available from: 1179 https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedoc 1180 uments/ucm089738.pdf , accessed 30 May 2019. 1181 (43) Food and Drug Adminstration. Nucelic Acid Based Tests. Available from: 1182 https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/uc 1183 m330711.htm , accessed 30 May 2019. 1184 (44) Food and Drug Adminstration (2005) 510(k) Premarket Notification for JBAIDS Anthrax 1185 Detection System. Available from: 1186

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