FDA offers real-world evidence examples in device applications

Regulatory NewsRegulatory News | 18 March 2021 |  By 

 The US Food and Drug Administration (FDA) is offering a detailed look at how real-world evidence sources – from registries to claims data – can be used to support marketing applications for medical devices.
A new report from the FDA’s Center for Devices and Radiological Health (CDRH) breaks down 90 examples in which real-world evidence was used to support final premarket or postmarket regulatory decisions from Fiscal Year 2012 through 2019. These examples include premarket notification 510(k) submissions, De Novo classification requests, humanitarian device exemption (HDE) applications, premarket approval (PMA) original applications, PMA panel track supplements, and continued access programs.
The FDA previously offered insight into how it evaluates real-world data for regulatory decisions on medical devices in guidance issued in 2017.
“The real-life clinical performance of a medical product might be more clearly demonstrated through [real-world data/real-world evidence] because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users,” CDRH Director Jeff Shuren, MD, JD, and Daniel Caños, PhD, MPH, director CDRH’s Office of Clinical Evidence and Analysis, wrote in an FDA Voices article.
The FDA provided 18 examples of applications that relied on real-world data collection made through national registries, and several other using international registries, sponsor registries, or a combination of registries and other sources.
In one example, Prytime Medical Devices used registry data and a case series as the primary clinical evidence supporting modification of its indications for use statement for its Large Vessel Occlusion Catheter. The sponsor submitted a 510(k) application to add an indication for patients requiring emergency control of hemorrhage. The evidence came from the American Association for the Surgery of Trauma (AAST) Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry and a case series. The registry was established to collect observational data on patients treated with aortic occlusion. Critically injured patients in need of emergency hemorrhage control who were treated with the device were identified in the registry and data were analyzed on successful aortic occlusion, with and without imaging placement.
In another example, the device sponsor relied on multiple sources of real-world data for its PMA supplement. As part of a post-marketing condition of approval study for Boston Scientific’s implantable cardioverter-defibrillator EMBLEM S-ICD Subcutaneous Electrode, the sponsor utilized a national registry, remote monitoring device data, administrative claims, and data from the National Death Index.
“Usually, a new enrollment study requiring direct follow-up of patients of up to 5 years would have been required,” the FDA wrote in the real-world evidence report. “For this approval, the postmarket study will leverage an existing national registry, remote monitoring of device-generated data, claims data from public and private payers, and the national death index, using only data collecting during routine-care.”
A De Novo classification application for the Nordic Cycles web and mobile-based software app, designed to help plan or prevent a pregnancy, relied on patient-entered and patient-generated data from use of the app outside the US. The sponsor submitted outside-US data from 15,570 women (ages 18-45 years) who had registered in the software app. The data were analyzed to validate the accuracy of the app’s algorithm in identifying ovulation by temperature and luteinizing hormone. The sponsor also used the data to perform a subgroup analysis on women who had recently used (or had not used) hormonal contraception.
“When reviewing the use of [real-world evidence] to support a regulatory decision, the FDA relies on scientifically robust methods and approaches to determine whether the submitted [real-world evidence] is of sufficient quality to support the regulatory decision,” Dr. Shuren and Dr. Caños wrote. “Leveraging [real-world evidence] 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 [real-world evidence], 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.”


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