1. Food and Drug Administration. Federal Food, Drug, and Cosmetics Act. Available from: http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/. [Accessed August 30, 2015].
2. Reform, regulation, and pharmaceuticals—The Kefauver–Harris Amendments at 50;Greene;N Engl J Med,2012
3. Food and Drug Administration. FDA Modernization Act of 1997. Available from: http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm. [Accessed August 30, 2015].
4. Food and Drug Administration. Prescription Drug User Fee Act. Available from: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/. [Accessed August 30, 2015].
5. Code of Federal Regulations. Title 21. Chapter I, Subchapter H, Part 860. Medical Device Classification Procedures. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=860. [Accessed August 30, 2015].