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

Access this On-Demand Webinar here.*

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), will be 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.

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