May 2, 2019
“Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks. Through our Patient Preference Initiative, we’ve committed to seeking patient input on these types of topics to help inform our regulatory decision making. Through better collection and understanding of information that matters to patients, we can ensure our evaluation throughout the lifecycle of a medical device includes a better reflection of the patient experience," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "Today we’re seeking public feedback on a list of patient preference areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments and postmarket evaluation. By asking patients, industry members and researchers to provide comments and feedback on this list, we’re working to ensure that the valuable insights from patients continue to inform the agency’s decisions and understanding.”
The U.S. Food and Drug Administration 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 postmarket 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.
In addition to the identified patient preference-sensitive topics listed, the FDA is seeking feedback from the public on whether the list itself needs to be modified and is interested in information about existing studies that may already be available to help address the information the agency is seeking.
The FDA continues to value patient preference information and items such as this priority list will help ensure valuable insights from patients continue to inform the agency’s decision making. For example, patient preference information studies based on the priority areas could be used in the FDA’s regulatory decision-making. These efforts are part of the FDA’s Patient Science and Engagement program, efforts to get patient preference information into medical device decision-making and commitments for the reauthorization of the Medical Device User Fee Amendments of 2017.
- Federal Register Notice: List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments
- Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluation
- Priority List of Patient Preference-Sensitive Areas
- Patient Preference Information (PPI) in Medical Device Decision-Making
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.