Patients bring valuable insight about their conditions and offer important information to the U.S. Food and Drug Administration (FDA) about living with the condition and its treatments. Patient input can significantly impact the development, evaluation, and monitoring of medical devices.

Discover how the FDA’s Center for Devices and Radiological Health (CDRH) puts patients first with its Patient Science and Engagement Program.

Patient-Reported Outcomes and Medical Device Evaluation: From Conception to Implementation

CDRH recently published a peer-reviewed article in the Journal of Patient-Reported Outcomes covering the September 2020 FDA virtual public meeting, Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation. Along with a summary of key discussion points from the meeting, the article also presents a look at how PROs can impact healthcare in the future. Read the article and watch the September 2020 virtual public meeting recording on FDA.gov.

Do PRO Measures Function the Same Way for All Individuals with Heart Failure?

Women experience heart failure differently than men and their different experiences may change how they understand questionnaires about heart failure symptoms. When using these questionnaires in medical device studies, it is assumed that all patients understand the questions in the same way. If they don’t, the comparisons between groups answering the questionnaire may be biased and impact how we evaluate medical device performance. This article describes how to look at whether men and women understand questions in different ways, why this is important in heart failure research, and what can be done in the future. Read the article in the Journal of Cardiac Failure.

Risk Communication for Patient Preference Studies

CDRH worked with Duke University, University of Michigan, and Beth Israel Deaconess Medical Center to test how different ways of displaying risk information might impact patients’ understanding of risks. The study results support presenting information about each risk separately rather than combining information about the risks. The study results also suggest that including symbols may help patients with a lower understanding of graphs better understand risk information. Read the findings and view the poster.

Patient-Focused Drug Development Draft Guidance

The FDA released a draft guidance on Patient-Focused Drug Development on June 29, 2022. When finalized, this would be the third in a series of four methodological patient-focused drug development guidance documents that describe how stakeholders can collect and submit patient experience data. The draft guidance reflects the recommendations of all three human medical product centers at FDA, including CDRH. The recommendations in the draft guidance relate to selecting, developing, or modifying fit-for-purpose clinical outcome assessments (COAs). A COA is a measure that describes how a patient feels, functions, or survives. The draft guidance describes how stakeholders, including patients and caregivers, can collect and submit patient experience data to be used for medical product development. You can review the draft guidance on FDA.gov.

Patient Engagement Advisory Committee

On July 12 and 13, 2022, CDRH held its sixth Patient Engagement Advisory Committee (PEAC) meeting. The committee heard from patients on what factors the FDA and industry should consider when evaluating the benefits, risks, and extent of uncertainty in the benefit-risk information for Augmented Reality (AR) and Virtual Reality (VR) medical devices. The committee also discussed ways that patient perspectives can be incorporated into FDA and industry benefit-risk decision making, and the health care provider decision-making process related to using or prescribing this technology. Access the summary of the meeting and recording.

Expediting Innovation of Bioelectronic Implants for Vision Restoration

On October 24 and 25, 2022, CDRH is co-sponsoring a public workshop with the University of Pittsburgh entitled, "Expediting Innovation of Bioelectronic Implants for Vision Restoration." These implants provide one approach to treating patients with profound vision loss. The purpose of this workshop is to provide a forum for all stakeholders, including patients, clinicians, manufacturers, regulators, and professional societies to share their perspectives on the safety and effectiveness of bioelectronic implants for vision restoration. View the agenda and register for the workshop.