SPADA Docs

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(33) Westgard, J.O. (2008) Basic Method Validation , Third Edition, Westgard Quality

Corporation, Madison, WI. 1143 (34) Clinical and Laboratory Standards Institute (2004) Evaluation of precision performance of 1144 quantitative measurement methods. Approved guideline, 2nd ed. CLSI document EP5-A2. 1145 Clinical and Laboratory Standards Institute, Wayne, PA . 1146 (35) Code of Federal Regulations (2009) 42 CFR 493.1253 - Standard: Establishment and 1147 verification of performance specifications. U.S. Government Printing Office, Washington 1148 DC, https://www.ecfr.gov/cgi-bin/text- 1149 idx?SID=dd25ed1e1fc03826036c4fa105249ccd&mc=true&node=pt42.5.493&rgn=div5#se 1150 42.5.493_11253 , accessed 30 May 2019. 1151 (36) Clinical and Laboratory Standards Institute (2003) Evaluation of the linearity of 1152 quantitative measurement procedures: a statistical approach. Approved guideline. CLSI 1153 document EP6-A, Clinical and Laboratory Standards Institute, Wayne, PA. 1154 (37) Food and Drug Administration, Section 564 of the Food Drug, and Cosmetic (FD&C) Act 1155 was amended by the Project Bioshield Act of 2004 and was further amended by the 1156 Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st 1157 Century Cures Act of 2016, and Public Law 115-92 of 2017. 1158 (38) Food and Drug Adminstration (2017) Guidance for Industry and Other Stakeholders: 1159 Emergency Use Authorization of Medical Products and Related Authorities . Office of 1160 Counterterrorism and Emerging Threats. Available from: https://www.fda.gov/regulatory- 1161 information/search-fda-guidance-documents/emergency-use-authorization-medical- 1162 products-and-related-authorities, accessed 30 May 2019. 1163

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