1. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM296379.pdf . Accessed 2 Sept 2014
2. Section 513(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(a)]
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4. Shuren J, Woodcock J (2013) Reviewing FDA’s implementation of FDASIA. http://www.fda.gov/NewsEvents/Testimony/ucm374544.htm . Accessed 2 Sept 2014
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