FDA Seeks Feedback on Patient Preferences Related to Medical Devices

Posted May 6, 2019

Expanding its commitment to integrating patients' voices into regulatory decision making, the Food and Drug Administration (FDA) is seeking feedback on a proposed list of patient preference studies for medical devices.

While recognizing the roles of a variety of stakeholders (e.g., clinicians, device developers, regulators) in evaluating and disseminating information related to benefits and risks of medical devices, the Center for Devices and Radiological Health (CDRH) wrote that "only patients live with their medical conditions and make daily choices regarding their health care." The CDRH explained its thinking on its Patient Preference Information (PPI) in Medical Device Decision-Making webpage.

PPI is vital to informing medical device design, the design of clinical studies, and gaining an understanding of how study results will affect patients, according to CDRH. The agency said that gathering PPI can have a variety of benefits, including:

  • Capturing patient perception related to the greatest benefits and risks of a technology.
  • Determining patient-perceived value of clinical study outcomes.
  • Assessing how patients think about the tradeoffs of a given technology's benefits and risks.
  • Clarifying how preferences related to the benefits and risks of treatment options vary across patient populations.

CDRH highlighted its involvement in several ongoing collaborations related to the acquisition of PPI, including the Medical Device Innovation Consortium (MDIC) Science of Patient Input initiative and MDIC Patient Centered Benefit-Risk Framework project.

Further, FDA scientists have been involved in a variety of patient preference studies, including ones related to medical devices for obesity, amputation, and Parkinson's disease.

CDRH also is encouraging device manufacturers and other stakeholders to "consult with CDRH early when considering patient preference studies." To discuss a current or potentially forthcoming patient preference study, study sponsors and interested parties should email CDRH-PPI@fda.hhs.gov and can request a Q-Submission meeting.

While noting that the PPI "does not change any review standards for medical devices," the agency encouraged "medical device manufacturers to consider the impact of patient preference information across the entire life cycle of a device—from the development and evaluation to the surveillance of the device once it is sold in the United States."