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Public Citizen Urges the FDA to Retract Industry-Centered “Patient Preference” Guidance

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In comments submitted today, Public Citizen urges the Food and Drug Administration (FDA) to retract its recent draft guidance discussing how the agency will use “patient preference” information when making decisions about whether to approve high-risk medical devices. We argue that the guidance was heavily influenced by members of regulated industry and would lower approval standards for high-risk medical devices.