FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices

FDA

2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority list of patient preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments and post-market evaluation. 

The priority list, developed based on public input the agency previously received, is intended to provide greater clarity about areas in which the FDA would find patient preference information most informative for medical device regulatory decisions.

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 list posted today seeks input on several parameters the agency can use to identify patient preference-sensitive areas to incorporate into medical device review, such as: significant public health impact; areas where patients may value the benefits and risks of a technology or treatment differently from healthcare professionals and/or caregivers; and areas where population-level differences in patient perspectives are not well understood due to a variety of factors.

Read FDA press release

Michael Wonder

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Michael Wonder