Using Patient-Reported Outcomes in FDA Submissions

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PROs play a key role in the development, design, evaluation, and surveillance of medical devices, and in regulatory and payor decision-making. Device regulatory expert Kevin Go highlights some important considerations for device regulatory teams to keep in mind if they are using PROs in FDA submissions.

The most critical end-user of any medical device is, of course, the patient. The patient’s point of view on living with and managing their specific health condition is, with FDA support, increasingly being incorporated into the development, design, evaluation, and surveillance of medical devices. Patient-reported outcome (PRO) instruments, including information obtained directly from the patient without physician input, in formats such as questionnaires, diary entries, and numeric rating scales, are often not directly measurable with other tools. These PRO instruments facilitate the systematic collection of how these individuals feel, function, and survive as critical and valid scientific evidence to support the regulatory, reimbursement, and healthcare decision-making process.

Market Pathways recently spoke with Kevin Go, a former FDA staffer now working as a Senior Engineer at Monroeville, PA-based Regulatory and Quality Solutions LLC, about using Patient-Reported Outcomes in FDA submissions. Go spoke on this topic recently at AcKnowledge Regulatory Strategies’ Virtual Regulatory Alliance Forum (RegAF) conference, held August 17-19.

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