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)...

1. Real World Evidence in the MedTech Industry
By: Madison Wheeler
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!
1 FDA (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
2 FDA (March ) Examples of RWE Used in Medical DeviceRegulatory Decisions retrieved on 03/21/2021 from:
https://www.fda.gov/media/146258/download