FDA Issues Two Final Guidances on Patient Science and Engagement in Medical Device Clinical Studies

Today, the U.S. Food and Drug Administration (FDA) issued two final guidances to provide recommendations for including patient perspectives in medical device clinical studies.

Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

This final guidance:

• Describes how device developers, sponsors and industry can voluntarily use patient engagement to improve clinical study design and conduct.
• Provides examples of approaches to consider when device developers, sponsors and industry wish to incorporate patient advisor input in clinical studies.
• Describes which patient engagement activities are generally not considered by the FDA to constitute an activity subject to the FDA’s regulations regarding Institutional Review Boards (IRBs).
• Clarifies how sponsors can receive feedback from the FDA on plans to voluntarily include patient advisors’ input on their clinical study through the Q-submission process.

Read the Guidance

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

This final guidance:

• Describes principles that may be considered for instruments that capture and measure patient-reported outcomes.
• Provides recommendations about the importance of ensuring these instruments are fit-for-purpose.
• Outlines best practices for selecting, developing, modifying, or adapting a patient-reported outcome instrument for use in medical device evaluation.

Read the Guidance

Upcoming webinars on these guidances

• On March 1, 2022, the FDA will host a webinar for industry and others interested in learning more about the Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation guidance.
• On March 22, 2022, the FDA will host a webinar for device developers, sponsors, industry and others interested in learning more about the Patient Engagement in the Design and Conduct of Medical Device Clinical Studies guidance.

Questions?

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