Because the U.S. Food and Drug Administration (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, the agency asks device manufacturers to include this type of input when submitting applications for FDA approval. 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. This type of information can be included in clinical studies, benefit-risk assessments, and post-market surveillance. Patient preference information can also clarify what benefits and risks are most important to patients.
Patient preference 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 post-market evaluation of medical devices. Patient preference-sensitive areas may be cross-cutting topics related to approaches of delivering treatment (such as minimally invasive approaches) or related to specific diseases and conditions.
The recently published proposed priority list is not an exhaustive list of all patient preference-sensitive areas for medical devices but is intended to provide examples of these areas. In addition, these areas may shift over time as more patient preference studies are done and as technology evolves.
*Note: this information has been reprinted directly from the FDA website.