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  1. Division of Patient-Centered Development

Patient Preference Information (PPI) in Medical Device Decision Making

The Center for Devices and Radiological Health (CDRH) recognizes that it takes many people to evaluate and communicate the benefits and risks of medical devices. However, only patients and their caregivers who have lived with their medical conditions and use medical devices understand the factors that impact their health care choices and the patients' perspectives are critical to understanding the impact of medical devices on their daily lives.

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About Patient Preference Information

Patient-preference information (PPI) captures the value patients place on features of medical devices. PPI includes different patient perspectives on the benefits and risks of using medical devices and treating medical conditions. PPI is different from patient-reported outcomes which are part of a clinical trial and measure how patients feel and function.

Well designed and conducted PPI studies elicit which attributes are important to patients, how important they are, and what tradeoffs patients are willing to make amongst them. PPI is also referred to as health-preference assessment, stated-preference health survey, health-preference research, and patient-centered research in the scientific literature.

Many groups conduct patient preference studies, such as:

  • Patient groups
  • Members of the medical device industry
  • Researchers
  • Professional societies
  • Health care providers
  • Public and private partners

As the medical device community conducts more PPI studies, CDRH gains a better understanding of what patients value and the tradeoffs they are willing to make.

Patient Preference Information to Help CDRH Understand Medical Device Benefits and Risks

Risk And benefit wooden blocks on seesaw

PPI 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.

PPI helps to:

  • Find unmet patient needs early in medical device development.
  • Identify the most important benefits and risks of a technology from a patient's perspective.
  • Assess patients' views on different clinical study outcomes.
  • Determine a meaningful change in clinical study outcomes.
  • Clarify what patients think about the tradeoffs of the benefits and risks for a treatment or diagnostic.
  • Clarify how patient preferences on benefits and risks vary among diverse groups and their willingness to accept uncertainty about the benefits and risks.

PPI has been used in multiple submissions for Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests which has informed CDRH's regulatory decision making.
For example:

  • An FDA-sponsored PPI survey related to obesity devices informed an approval for a medical device to treat obesity.
  • Ear infections are common in children and are often treated with antibiotics. Children who experience multiple ear infections may need ear tubes to prevent ear infections. These tubes are often placed in the operating room. A medical device company developed a product that allows doctors to place ear tubes in pediatric patients in their office. The company used a PPI study to help inform the design of the clinical trial for the product.
  • Home hemodialysis has rare but serious adverse events so a caregiver or trained partner must be present. However, a medical device company conducted a PPI study that showed some patients were willing to accept risks so they could do dialysis at home alone. This PPI study informed CDRH's decision to expand the labeled indications for the home hemodialysis device.
  • Collecting information from patients helped enhance glucose monitor and insulin pump safety for children. CDRH discussed concerns with patients and parents about the safety of using an insulin pump in pediatric patients. Based on this feedback, CDRH worked with a medical device company to develop additional risk mitigations to include a lockout feature and prevent unintended insulin doses.

For more information, see How Patient Preferences Contribute to Regulatory Decisions for Medical Devices.

Patient Preference Information Resources

CDRH is committed to including patients' voices into our decision making. We acknowledge PPI is an active and evolving research area. We continue to partner with patient groups, members of the medical device industry, researchers, professional societies, health care providers, and public and private partners to advance PPI studies.


Published Studies and Ongoing Projects

FDA scientists frequently collaborate with a variety of stakeholders to conduct PPI studies to inform clinical trial design and medical device regulatory decision making. Examples include medical devices for:

Sample Blogs and Articles

FDA Workshop Transcripts and Recordings

Conducting a Patient Preference Information Study

Groups interested in starting or conducting a PPI study should email CDRH-PPI@fda.hhs.gov. You may request a pre-submission meeting to discuss a potential or current PPI study. We encourage medical device manufacturers and other stakeholders to consult with CDRH early when considering PPI studies.

The FDA remains committed to assuring that medical devices are safe and effective. The FDA encourages medical device manufacturers to consider the impact of PPI across the entire life cycle of a medical device. Including PPI does not change any review standards for medical devices.

For more information, refer to these guidance documents:

Contact Information

If you have questions about PPI, email CDRH-PPI@fda.hhs.gov.

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