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Medical Devices / Regulatory Affairs

FDA Seeks Comments on Patient Preferences

May 3, 2019

The FDA invited stakeholder comments  on a new priority list of patient preferences that could impact the design of premarket studies for devices.

The FDA wants feedback on several factors, including areas where population-level differences in public perspective aren’t well understood.

“Patient preference information can inform the design of a medical device, impact how a clinical study is designed and be used to understand the impact of the clinical study results on patients,” the agency said.

The priority list looks to define areas in which patient preference information can contribute to the agency’s regulatory decisions for devices.

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