Data Device

Guidance on use of real-world evidence for devices and diagnostics

Real-world evidence is often used to assess the safety of devices and diagnostics. For instance, the FDA’s ,
Postmarketing Surveillance Program includes the FDA Adverse Event Reporting System (FAERS); FDA may also require some MedTech companies to conduct Post-Approval Studies. However, as new legislation (e.g., 21st Century Cures Act) has passed and new technology has been developed, the use of real-world data is increasingly being used. Some examples include:

Beside international and US organizations, many other countries are requiring the use of real-world evidence to monitor the safety of medical devices and diagnostics. For instance, Singapore’s HSA requires real-world adverse event reporting based on the use of medical devices. Other examples include:

In short, regulators are increasingly requiring that safety information for medical devices and diagnostics comes not just from clinical trials, but also from real-world data.

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