FDA Issues Guidance on Patient Engagement in the Design and Conduct of Device Studies

January 25, 2022—The FDA announced the agency issued two final guidance documents, linked below, that provide recommendations for including patient perspectives in medical device clinical studies.

The first is Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.

As outlined by the FDA, this final guidance does the following:

• 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.
• 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.

The second document is Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.

The FDA stated this final guidance does the following:

• 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.