About FDA

Patient Preference Initiative

The Center for Devices and Radiological Health (CDRH) recognizes that while scientists, clinicians, device developers, and regulators play critical roles in understanding and communicating the benefits and risks of medical devices, only patients live with their medical conditions and make choices regarding their personal care. They provide a unique voice and unique perspective.

The goal of the Patient Preference Initiative (PPI) is to develop a systematic way of eliciting, measuring, and incorporating patient preference information, where appropriate, into the medical device Total Product Life Cycle. Ultimately, the objective is to drive more patient-centric innovation, evaluation, and delivery to U.S. patients. As part of this initiative, CDRH seeks to advance the science of measuring patient preferences by developing guidance for industry and other stakeholders on how to assess patient valuations of benefit and risk related to relevant device types and specific illnesses and conditions.

CDRH gets patient preference information from patient groups, industry, and others who conduct studies, in device submissions, and from listening to patients’ input through advisory panel meetings, public-private partnerships, public workshops and public comments submitted to FDA. As the medical device community conducts more patient preference studies, we will gain a better understanding of the tradeoffs that patients are willing to make in order to have access to new devices.

Listening to Patients' Views

While patient representatives participate in many of the FDA's advisory committees, including CDRH’s advisory panels, the FDA has never had a committee that was wholly focused on patients.

Now the Patient Engagement Advisory Committee allows the FDA to hear from multiple patients, patient advocacy groups, and experts. Rather than focusing on a product or specific disease, the committee will be asked to weigh in on a variety of important patient-related issues. 

We Continue to Put Safety and Effectiveness First

While it's important to consider patient perspectives, we understand that patients still expect us to do our job – assure the safety and effectiveness of medical devices available for U.S. patients. In considering the patient perspective, the FDA remains committed to assuring that devices meet the requisite standards.

In our final guidance on patient preference information, the FDA encourages medical device manufacturers to voluntarily include in their premarket submissions information about the tradeoffs patients may consider when evaluating the benefits and risks of a treatment option. The final guidance does not change any review standards for these types of submissions. It includes recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and patient advocacy organizations, can voluntarily collect and submit to FDA patient preference information. It also outlines how the FDA includes patient preference information in FDA’s decision summaries that explain what information the FDA relied on in its approval or marketing authorization of the product.

As the medical device community conducts more patient preference studies, we will gain a better understanding of the tradeoffs that patients are willing to make when weighing their treatment options. The FDA encourages medical device manufacturers to consult with the Agency early when considering patient preference studies.

Patient Preference Information Helps Us Understand Device Benefits and Risks

Patient preference information is part of the information that CDRH considers when assessing the benefits and risks of a device. Patient preference information can help in several major ways:

  • identify the most important benefits and risks of a technology from a patient's perspective
  • clarify how patients think about the tradeoffs of these benefits and risks for a given technology
  • show how patient preferences vary across a population, regarding benefits and risks of various treatment options

As on example of where patient input was used to improve how new devices are studied — In January 2015, a team of FDA scientists published an article in Surgical Endoscopy in collaboration with RTI Health Solutions, a business unit of RTI International, presenting how they tested a new method for capturing patient sentiment and translated it into a decision-making tool for incorporating patient preferences into clinical trial design for new obesity treatments. They were able to estimate the tradeoffs in risks that obese patients are willing to accept in exchange for a certain amount of weight loss, and the minimum number of pounds they would have to lose to tolerate the risks of a weight loss device.

What Happens Next with Patient Preference Information

CDRH is committed to integrating the patient voice into our decision-making. We acknowledge that patient preference assessment is an active and evolving research area. We hope this initiative serves as a catalyst for continued advancement of the science of patient input, through continual development and refinement of methods for eliciting patient preferences regarding benefits and risks associated with use of medical products.

To get updates about CDRH's Patient Preference Initiative, subscribe to the U.S. Food & Drug Administration (FDA) free e-mail subscription service.

More information about how the FDA assesses benefits and risks of devices can be found in CDRH's Benefit Risk Guidance.

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Page Last Updated: 09/27/2018
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