Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices

• Activity Number: 575 - Translating Real World Data into Robust Evidence to Inform Decisions on Medical Product Development and Life Cycle Management
• Type: Topic Contributed
• Date/Time: Wednesday, August 1, 2018 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Martin Ho*
• Companies: FDA
• Keywords: medical devices; real-world evidence; patient-generated data; patient preference elicitation; medical device registry; patient-reported outcome

Abstract

FDA Center for Devices and Radiological Health (CDRH) released its final guidance document for industry and staff on "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" in August 2017. The guidance was motivated and shaped by CDRH's experience of using real-world evidence (RWE) as supplemental evidence that fills the gaps of traditional clinical trial to inform its benefit-risk assessment of medical devices. Since the guidance's release, CDRH has promoted RWE as an important approach to fulfill its mission and vision of granting patients quicker access to safe and effective devices. CDRH has not only made substantial investment in seeding the infrastructure of RWE collection, it has also accumulated substantial experience making RWE-informed regulatory approvals. This presentation will describe how RWE informs decision making at CDRH from a statistical perspective. I will start with a brief background about the regulatory questions CDRH faces and define RWE. Then, I will describe the statistical machinery behind medical devices evaluation using RWE with an example and conclude with remarks on the future roles of RWE in regulatory science.