Patients are knowledgeable regarding their conditions and offer valuable 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.

Announcing Virtual Patient Engagement Advisory Committee (PEAC) Meeting to Discuss Augmented Reality (AR) and Virtual Reality (VR)

On July 12-13, the U.S. Food and Drug Administration (FDA) is hosting a virtual meeting about Augmented Reality (AR) and Virtual Reality (VR) Medical Devices. During this meeting, the Patient Engagement Advisory Committee (the Committee) will discuss and make recommendations on factors to consider when evaluating the benefits, risks, and uncertainty for AR/VR devices. The Committee will also discuss specific challenges related to vulnerable populations, such as children, who may use this technology.

The FDA encourages you to save the date for the upcoming PEAC meeting:

• Meeting Dates:
  • Tuesday, July 12, 2022, 10 a.m. - 4.p.m. EST
  • Wednesday July 13, 2022, 10 a.m. - 2 p.m. EST
• Location: This is a public meeting and will be webcast
• Registration: No registration required. View webinar details for call-in information
  
  

Patient Science and Engagement Guidances

On January 26, the FDA, issued two final guidances:

• Patient Engagement in the Design and Conduct of Medical Device Clinical Studies. Read the guidance.
• Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. Read the guidance.

If you have questions about these final guidances, please contact the Division of Industry and Consumer Education.

On March 1, the FDA hosted a public webinar to discuss the Final Guidance, “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” This guidance outlines the principles device manufacturers should consider when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices. It also provides recommendations about the importance of having the right evidence to support the use of a measure. Materials for the webinar, slides, transcripts, and recording are publicly available on CDRH Learn under Specialty Topics → Patient Engagement. The final guidance is available here.

On March 22, the FDA hosted a public webinar to discuss the Final Guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.” This guidance document describes how device developers, sponsors and industry can voluntarily use patient engagement to improve clinical study design and conduct. Materials for the webinar, slides, transcripts, and recording are publicly available on CDRH Learn under Specialty Topics → Patient Engagement. The final guidance is available here.

New Research Article on Patient-Reported Outcomes in FDA Marketing Authorizations

CDRH’s Patient Science & Engagement Program recently published the peer-reviewed research article Inclusion of Patient-Reported Outcome Instruments in US FDA Medical Device Marketing Authorizations in the Journal of Patient-Reported Outcomes. The article examines how the patient voice has been incorporated into medical device evaluation using patient-reported outcome (PRO) instruments. During a six-year period (October 1, 2014- September 30, 2020), PROs were used in about half of medical devices receiving marketing authorizations. This number may grow with further stakeholder collaborations to develop and modify PRO instruments for use in medical device evaluation. Read the article.

Acceptability of Patient-Reported Outcome Instruments for Heart Failure in an Underserved Patient Population

CDRH partnered with the University of California San Francisco to study how acceptable the shorter version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is among racially and ethnically diverse patients receiving care in an urban, safety-net setting. The study found that while patients were receptive to the KCCQ-12 as a tool, they perceived that the tool did not adequately capture key health components, such as mental health, to manage heart failure. Further study on the incorporation of social determinants of health into patient-reported outcome measures could make these tools more useful in evaluating and managing heart failure in diverse, underserved populations. Read the article.