How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

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Often, real-world data (RWD) routinely collected during patient treatment and management provides tangible information pertaining to the experiences of medical device end-users. These data sources range from medical device registries, electronic health records (EHRs), claims and billing data, patient-generated information, and even data gathered from mobile devices. Under the right conditions, information derived from these sources can be utilized to support various medical device regulatory pathways and decisions.

Recognizing the wealth of RWD available to global medical device manufacturers that may support regulatory pathways, the U.S. Food & Drug Administration (FDA) issued guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” on August 31, 2017. This document provides a better understanding of how the FDA evaluates RWD to determine whether it is sufficient for generating real-world evidence that can support FDA medical device regulatory decision-making.

This NAMSA Webinar, provided in partnership with the Medical Alley Association (MAA), was presented by Owen Faris, PhD; Director of Clinical Trials Program, FDA Office of Device Evaluation, and Chris Mullin; Director of Product Development Strategy, NAMSA.

• Following attendance at this webinar, registrants will be able to:
• Explain the rationale for using real-world evidence in regulatory decision-making;
• Elaborate on the factors that the FDA considers when reviewing RWD;
• Provide examples of how RWD is being utilized by the agency today; and
• Understand best practices and resources available for securing and using RWD with the FDA.

Presenter Information

Owen Faris, PhD; Director of Clinical Trials Program, FDA Office of Device Evaluation
Dr. Faris has served as the U.S. FDA’s Clinical Trials Director for the Center for Devices and Radiological Health (CDRH) since its inception in February 2014. In his current role, he oversees the FDA’s decisions and policies for medical device clinical trials, including early feasibility studies and the CDRH’s Breakthrough Devices Program. He originally joined the FDA in 2003 as a Reviewer in the Pacing, Defibrillator and Leads Branch in the Division of Cardiovascular Devices (DCD) and was appointed to the position of Deputy Director for the Division of Cardiovascular Devices in 2011. Dr. Faris serves as the Co-Chair of the CDRH Strategic Priority Effort focused on the access and use of RWD for regulatory decision-making. He holds a Bachelor of Science in Mechanical Engineering from Rice University and a PhD in Biomedical Engineering from Johns Hopkins University.

Chris Mullin; Director of Product Development Strategy, NAMSA
Chris Mullin is currently the Director of Product Development Strategy at NAMSA where oversees and manages client partnerships surrounding product development and market commercialization strategies.

Mr. Mullin began his career working on National Institute of Health (NIH)-funded clinical trials, and over the last ten years, he has consulted for medical device organizations throughout the U.S. Asia, and Europe on various clinical trial programs.

A highly sought-after industry expert, Chris has helped hundreds of global manufacturers optimize study design and research, providing proven strategies to address regulatory requirements for market approval and introduction. Chris has worked with multiple innovative technologies across a wide array of therapeutic areas, which has allowed him to provide valuable perspectives to clients on scientific and regulatory challenges – and suggested strategies for success – that impact the advancement of novel medical technology.

Chris has authored multiple peer-reviewed publications a book chapter on clinical study design for translational research, and serves  as a journal editor. Chris holds a Master’s Degrees in Biostatistics from the University of Minnesota. He earned his Bachelor’s Degree at the University of Wisconsin-Madison in Mathematics.

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