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FDA Seeks Input on Patient Preference Information for Medical/Dental Device Regulation

The United States Food and Drug Administration (FDA) has announced availability of Patient Preference Information: Patient Preference-Sensitive Priority Areas on  The FDA believes that patients can and should bring their experiences to help inform the FDA’s evaluation of medical/dental devices over the total product life cycle.  As a result, the Center for Devices and Radiological Health (CDRH) will expand its work on patient preferences and identify priority areas where patient preference data may help inform regulatory decision-making.  This effort also fulfills part of the FDA’s commitments for reauthorization of MDUFA IV.  The Priority List of Patient Preference-Sensitive Areas is intended to provide greater clarity to researchers and industry members about areas in which CDRH would find patient preference studies most informative for medical/dental devices.  The FDA seeks feedback on the Priority List of Patient Preference-Sensitive Areas.  The FDA is also interested in receiving input on these questions:
  1. Do any existing topics on the Priority List of Patient Preference-Sensitive Areas need to be refined to better represent preference-sensitive areas important to regulatory efforts?  And if so, how?  Provide an explanation to support any recommended refinements.
  2. Are there other areas not listed on the Priority List of Patient Preference-Sensitive Areas that FDA should consider as priority preference-sensitive areas?  If there are additional areas for consideration, identify and provide an explanation for each area using the parameters outlined in the Priority List of Patient Preference-Sensitive Areas.
  3. Are there ongoing studies or published studies that adequately address these preference-sensitive areas in a regulatory context?  If so, provide information or references regarding the studies.


Patient preference information can help inform regulatory decision-making by clarifying what benefits and risks are most important to patients.  Patient preference studies conducted in preference-sensitive areas may impact the design and conduct of premarket clinical studies, benefit-risk assessments, and postmarket evaluation of medical/dental devices.  Learn more about CDRH’s work with Patient Preference Information.  If you have general questions about Patient Preference Information, contact: