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US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health and Center for Biologics Evaluation and Research (2016) Patient Preference Information—Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and de Novo Requests, and Inclusion in Decision Summaries and Device Labeling. Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders.
http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ UCM446680.pdf

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