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Original Articles

Incorporating Patient Preferences into Medical Device Benefit-Risk Assessments

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Pages 230-236 | Received 01 Sep 2015, Published online: 16 Sep 2016

References

  • Food and Drug Administration (FDA) (2012), Guidance for Industry and Food and Drug Administration Staff: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, Silver Spring, MD: U.S. Food and Drug Administration, Center for Devices and Radiological Health.
  • ——— (2015a), Patient Preference Information—Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling, Silver Spring, MD: U.S. Food and Drug Administration, Center for Devices and Radiological Health.
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  • ——— (2015b), “Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013–2015,” available at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm
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