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

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

The U.S. Food and Drug Administration (FDA) issued two final guidance documents that provide recommendations for utilizing 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, the objectives in this 11-page document are to:

  1. Help sponsors understand how they can voluntarily use patient engagement to elicit experience, perspectives, and other relevant information from patient advisors to improve the design and conduct of medical device clinical studies;
  2. Highlight the benefits of engaging with patient advisors early in the medical device development process;
  3. Illustrate which patient engagement activities are generally not considered by FDA to constitute research or an activity subject to FDA’s regulations, including regulations regarding institutional review boards (IRBs); and
  4. Address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.

The second is Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation. The objectives in this 16-page document are to:

  1. Describe principles that may be considered when using patient-reported outcome (PRO) instruments in the evaluation of medical devices;
  2. Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose and;
  3. Outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach.

For clarification, both documents state: “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.”