Real World Evidence in the MedTech Industry

by | Mar 22, 2021 | FDA, Medical Devices, MedTech, Quality, Real World Evidence, Regulatory

Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has recently pushed for an increase in using RWE to support regulatory submissions, in an effort to promote public health. To define what constitutes RWE, we must first start with defining Real World Data (RWD).

RWD is routinely collected from a variety of sources; mainly electronic health records (EHR’s), product/disease registries, claims activities, and patient-generated data such as in-home use settings.1 This data is important since it comes directly from real use cases, and can also be used to support the monitoring of post-market safety and adverse events. RWE is the clinical evidence of the potential benefits or risks of a medical product that is derived from the analysis of RWD. The RWE is essentially the conclusion that you come to after reviewing all RWD.

Major industry players, such as Medtronic, Johnson & Johnson, and Abbott have all pushed the RWE effort along. Earlier this month the FDA released a report on RWE used in Medical Device Regulatory Decisions, which outlined 90 examples that spanned from 2012 through 2019 over a spectrum of devices and submission types. In this report, you can see that nearly 40% of the examples are PMA’s, 510(k)’s, and De Novo classification requests. There are also examples of Humanitarian Device Exemption filings and PMA panel track supplements.2

This report highlighted how these industry giants are using RWE as clinical evidence to support the regulatory submissions of their products. In addition to using RWE to support their filing with the FDA, these firms also made important continuous improvement decisions based on the evidence; this includes setting up registries or additional types of controls for their product.

The FDA is continuously looking for ways to optimize its regulatory submission processes; not only for efficiency for the industry but also to provide better protection for public health. Medical device manufacturers can expect that the use of RWE will shift from “nice to do” to industry standard as the effort progresses. If you are preparing for a regulatory submission for your product, EMMA International can help! Our team of regulatory experts stays on top of trends in the industry and can help make sure your submission includes all of the elements that the FDA wants to see. Give us a call at 248-987-4497 or email us at info@emmainternational.com to get started today!


1FDA (n.d.) Real World Evidence retrieved on 03/21/2021 from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

2FDA (March ) Examples of RWE Used in Medical Device Regulatory Decisions retrieved on 03/21/2021 from: https://www.fda.gov/media/146258/download

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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