FDA Seeks Feedback on Priority Areas for Patient Preferences on Medical Devices

Today, the Food and Drug Administration announced availability of Patient Preference Information: Patient Preference-Sensitive Priority Areas on FDA.gov.    We believe that patients can and should bring their experiences to help inform the Agency’s evaluation of medical devices over the total product lifecycle.  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. We Want Your Feedback on the Priority List 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 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: 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? Please provide an explanation to support any recommended refinements. 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, please identify and provide an explanation for each area using the parameters outlined in the Priority List of Patient Preference-Sensitive Areas. Are there ongoing studies or published studies that adequately address these preference-sensitive areas in a regulatory context? If so, please provide information or references regarding the studies.

Provide Feedback

Patient Preference Information 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 devices. Learn more about CDRH’s work with Patient Preference Information.   Questions? If you have general questions about Patient Preference Information contact CDRH-PPI@fda.hhs.gov.