FDA issues two final guidances for including patient perspectives in medical device studies


The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.  

As per an FDA press release, the finalised version of the first of these two guidance documents, entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies”, features key points including:

  • Describing how device developers, sponsors and industry can voluntarily use patient engagement to improve clinical study design and conduct
  • Providing examples of approaches to consider when device developers, sponsors and industry wish to incorporate patient advisor input in clinical studies
  • Describing 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)
  • Clarifying 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 of these two newly issued guidances, entitled “Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation”, intends to:

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


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