USA – US FDA releases draft guidance on patient-reported outcome instruments

The US Food and Drug Administration released a draft guidance document on August 31 that aims to help medical device manufacturers, FDA staff, and other stakeholders utilize patient-reported outcome (PRO) instruments for medical device evaluation. PRO instruments (alternatively called patient-reported outcome measures or PROMs) are questionnaires designed to record PROs in the form of data that can be utilized for clinical assessment of a device’s safety and effectiveness. According to the guidance, PRO instruments “facilitate the systematic collection of how patients feel, function, and survive as valid scientific evidence to support the regulatory and healthcare decision-making process.”

FDA efforts to give greater weight to PROs in its regulatory and clinical activities date back to at least 2015, when the Agency created the Patient Engagement Advisory Committee to further the cause of patient-centered healthcare. The FDA’s Center for Devices and Radiological Health (CDRH) also announced in 2016 that more effectively generating data from PRO instruments would be one of its key priorities…