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The FDA’s Center for Devices and Radiological Health (CDRH) plans to host a meeting of its Patient Engagement Advisory Committee in October 2024 to explore and solicit recommendations on enhancing patient-centered informed consent policies. This discussion will not be limited to medical devices but will extend to all FDA-regulated medical products. The committee will focus on the current informed consent process, identify new areas that require attention, and review recent policies regarding the essential information that should be communicated to patients.
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