1. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm
2. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm
3. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications;Guidance for Industry and Food and Drug Administration Staff,2016
4. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)];Guidance for Industry and Food and Drug Administration Staff,2014
5. Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf. Accessed July 8, 2010