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Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluation

Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluation

The FDA believes that patients can and should bring their own experiences to bear in helping inform the agency’s evaluation of medical devices over the total product lifecycle. This kind of input can be important to consider during the FDA’s decision-making for medical devices including in clinical studies, benefit-risk assessments, and postmarket surveillance.

Priority List of Patient Preference-Sensitive Areas
This list is intended to provide greater clarity to industry and researchers about areas in which CDRH would find patient preference studies most informative.
View the priority list

As part of the FDA Reauthorization Act of 2017, which includes the Medical Device User Fee Amendments IV (MDUFA IV), CDRH intends to:

  • Expand its capability in patient preferences (PDF – 293 KB)
  • Identify priority areas where decisions are preference-sensitive and can inform regulatory decision-making.

These efforts will help focus the FDA, device industry, researchers, and others toward designing and conducting patient preference studies in high impact areas.

What Is Patient Preference Information?

Patient preference information is defined as qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions.

Patient preference information can clarify what benefits and risks are most important to patients. Patient preferences information studies conducted to fill these gaps in patient preferences data (preference-sensitive areas) may impact the design and conduct of premarket clinical studies, benefit-risk assessments, and postmarket evaluation of medical devices.

For more information: Patient Preference Information (PPI) in Medical Device Decision-Making

Parameters for Identifying Priority Patient Preference-Sensitive Regulatory Areas

In 2017, the FDA cohosted a multi-stakeholder public workshop with the Centers of Excellence of Regulatory Science and Innovation (CERSI) entitled Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation.

Using feedback from the workshop, CDRH defined these parameters to assist in the identification of patient preference-sensitive areas for medical device review:

  • FDA staff are looking to better understand the full impact of the disease or condition and treatment options on patients and/or caregivers.
  • Patients may value the benefits and risks of a technology or treatment differently from healthcare professionals and/or caregivers.
  • Population-level differences in patient perspectives are not well understood because of differences in:
    • Demographic characteristics
    • Stages of a disease
    • Disease phenotype
  • There is significant public health impact (such as high mortality or morbidity rates and high prevalence rates of the disease or few treatment options available such as in rare diseases).

Submitting Comments on the Priority List of Patient Preference-Sensitive Areas

The FDA is soliciting comments on the Priority List of Patient Preference-Sensitive Areas. The FDA is interested in feedback from the public on the following 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? Please 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, please 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, please provide information or references regarding the studies.

For instructions on submitting comments to these questions or to the proposed Priority List of Patient Preference-Sensitive Areas, please refer to the Federal Register (FR) notice.

Planning to Conduct a Patient Preference Information Study?

FDA’s policy for including patient preferences information studies in regulatory decision-making for certain medical devices is in effect. Sponsors or other parties interested in initiating or conducting a patient preference study should email CDRH-PPI@fda.hhs.gov and may consider requesting a pre-submission meeting to discuss a potential or current patient preference study.

For more information: