SPADA Draft Documents

(30) Koch, D.D., & and Peters, T. (1999) in Tietz Textbook of Clinical Chemistry , Third Edition, 1047 C.A. Burtis & E.R. Ashwood (Eds), Saunders Co., Philadelphia, PA. 1048 (31) Westgard, J.O. (2008) Basic Method Validation , Third Edition, Westgard Quality 1049 Corporation, Madison, WI. 1050 (32) Clinical and Laboratory Standards Institute (2004) Evaluation of precision performance of 1051 quantitative measurement methods. Approved guideline, 2nd ed. CLSI document EP5-A2. 1052 Clinical and Laboratory Standards Institute, Wayne, PA . 1053 (33) Code of Federal Regulations (2009) 42 CFR 493.1253 - Standard: Establishment and 1054 verification of performance specifications. U.S. Government Printing Office, Washington 1055 DC, https://www.ecfr.gov/cgi-bin/text- 1056 idx?SID=dd25ed1e1fc03826036c4fa105249ccd&mc=true&node=pt42.5.493&rgn=div5#se 1057 42.5.493_11253 , accessed 30 May 2019. 1058 (34) Clinical and Laboratory Standards Institute (2003) Evaluation of the linearity of 1059 quantitative measurement procedures: a statistical approach. Approved guideline. CLSI 1060 document EP6-A, Clinical and Laboratory Standards Institute, Wayne, PA. 1061 (35) Food and Drug Administration, Section 564 of the Food Drug, and Cosmetic (FD&C) Act 1062 was amended by the Project Bioshield Act of 2004 and was further amended by the 1063 Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st 1064 Century Cures Act of 2016, and Public Law 115-92 of 2017. 1065 (36) Food and Drug Adminstration (2017) Guidance for Industry and Other Stakeholders: 1066 Emergency Use Authorization of Medical Products and Related Authorities . Office of 1067 Counterterrorism and Emerging Threats. Available from: https://www.fda.gov/regulatory- 1068

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