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May 7, 2019

The FDA Is Seeking Information on How Patients Choose Medical Devices

  • Government Relations News

The FDA is seeking feedback on a list of patient preference areas that it put together to help them take into account patients’ views as they make regulatory decisions about medical devices. Included on this list of patient preference areas is “Ear, Nose, and Throat: Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment options).”

The FDA is seeking information or qualitative or quantitative assessments of whether patients prefer certain alternatives, outcomes or choices over others in terms of their health.

The FDA wants to understand how patients view the risks and benefits of a technology or treatment differently from how the risks and benefits are viewed by health-care professionals and caregivers and whether differences in patient perspectives are not well understood due to a variety of factors.

Check out their request for comments on the Federal Register.

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