FDA’s CDRH reviews 90 examples of regulatory submissions regarding medical devices supported by real-world evidence
The US FDA’s Center for Devices and Radiological Health (C...
The US FDA’s Center for Devices and Radiological Health (CDRH; MD, USA) has published an analysis of 90 examples of regulatory submissions regarding medical devices – made between 2012 and 2019 – that were supported by real-world evidence.
The newly released analysis builds on the organization’s previously issued guidance in 2017, titled: ‘Use of real-world evidence to support regulatory decision-making for medical devices’, and aims to provide a more complete understanding of how real-world evidence can be used, to further its goal of fostering real-world evidence use in regulatory decision-making.
In a blog post accompanying the published analysis, Jeff Shuren, Director of the CDRH, and Daniel Caños, Director of the Office of Clinical Evidence and Analysis at the CDRH, wrote: “Advances in the availability of real-world data sources…have increased the potential to generate robust real-world evidence, to support FDA regulatory decisions.”
“[Real-world evidence] can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market,” Shuren and Caños added.
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The examples reviewed in the published analysis – which span the fiscal years 2012–2019 – leverage real-world evidence in submissions for premarket notifications and premarket approval original applications, amongst other submission types, and illustrate the diversity of uses of real-world evidence to support regulatory decision-making.
The sections of the report are organized by device type and real-world data source used, with the review containing six sections relating to: therapeutic devices, in vitro diagnostics, registries (national and international, and sponsor), claims data, medical records (including electronic health and medical records, and chart review) and other real-world data sources.
Shuren and Caños noted: “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.”
Source:
US Food and Drug Administration. Leveraging Real World Evidence in Regulatory Submissions of Medical Devices.
[Accessed 18 March 2021]