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A review of 90 medical device and diagnostics submissions that used real-world evidence or real-world data shows that RWE/RWD can be a powerful tool to not only better understand how products work outside the clinical trial setting, but also get treatments to patients faster, the US Food and Drug Administration says.

Over the past few years, the agency has heavily touted the benefits of using RWE to medtech sponsors at various forums and even developed the National Evaluation System for Health Technology (NEST) , which allows sponsors to get their product on the market with less premarket data as long as they provide additional RWD gathered in the postmarket setting. ()

The agency also published a 2017 guidance to explain to sponsors how reviewers intend to use RWE/RWD from product submissions when determining a product’s safety and effectiveness before allowing it on the market. ()

“The real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.” – Jeff Shuren, Daniel Caños

As part of the FDA’s efforts to understand the full impact of RWE/RWD, the Center for Devices and Radiological Health (CDRH) conducted a retrospective analysis of product submissions between 2012 and 2019 that used RWE/RWD. The agency honed in on 90 such submissions and published a report on 16 March concluding that use of RWE/RWD benefits reviewers, sponsors and patients.

CDRH director Jeff Shuren, who has led the effort to not just encourage manufacturers to use more RWE/RWD but to develop the agency’s policies for reviewers on how to integrate the information into its review process, published a blog post alongside Daniel Caños, director of the Office of Clinical Evidence and Analysis at CDRH, on the report’s findings.

“Advances in the availability of real-world data (RWD) sources – such as electronic health records (EHR), registries, medical claims, pharmacy data and feedback from wearables and mobile technology – have increased the potential to generate robust real-world evidence (RWE), to support FDA regulatory decisions,” the FDA officers said. “The real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

The report looked at a broad area of submissions and products that further cemented the agency’s arguments that RWE/RWD can be beneficial in a wide range of scenarios. More specifically regulators said they reviewed RWE/RWD in:

  • 18 premarket notification (510(k)) submissions;
  • 14 De Novo classification requests;
  • 2 humanitarian device exemptions (HDE) applications;
  • 20 premarket approval (PMA) original applications and
  • 37 PMA panel track supplements.


“These examples come from the full continuum of clinical and device areas throughout all seven Offices of Health Technology (OHT) in CDRH and represent only a subset of regulatory submissions that utilize RWD,” the FDA said in its report. “These examples represent a diversity in usage of RWD.”

Shuren and Caños picked out a number of device submissions to their office that have benefited from use of RWE/RWD, including automatic external defibrillators (AED), mobile software application for contraception, and modification to the indication for a large vessel occlusion catheter.

They also gave a shout-out to the FDA’s NEST program, which is meant to integrate data from clinical registries, EHRs and medical billing claims to develop a better long-term understanding of the safety and effectiveness of a product after it’s been allowed on the market. ()

“When reviewing the use of RWE to support a regulatory decision, the FDA relies on scientifically robust methods and approaches to determine whether the submitted RWE is of sufficient quality to support the regulatory decision,” Shuren and Caños said. “Leveraging RWE has provided CDRH with more timely access to a broader and richer set of safety information to better protect the American public and to inform our oversight of the total product life cycle.

“By unleashing the power of RWE, we can accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them, without compromising patient safety,” they added.

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