New medical device draft guidance from the Food and Drug Administration looks to clarify how the agency evaluates real-world evidence (RWE) to support decision making.
The FDA will abide by the criteria laid out in the guidance to determine if real-world data (RWD) sources are of good enough quality to be used as valid scientific evidence, the agency writes. Only such scientific evidence, it adds, can be used to assure a device is safe and effective.
Takeaways from the guidance include:
- The FDA will consider RWE in decision-making for medical devices if the real-world data sources used to gather the evidence “are of sufficient quality to provide confidence in the analyses necessary to inform or support the regulatory decision throughout the total product life cycle.”
- There is no one right kind of RWD source, but they should be chosen based on whether they can address regulatory questions and “should not dictate, interfere with or alter the normal clinical care of the patient.” If RWE is determined from multiple data sources, they must each be evaluated, both individually and together.
- To determine the reliability of RWD, the FDA will examine how the data was gathered, whether the dataset is complete and accurate, that it has minimized bias and that its integrity is sufficient.
The guidance also outlines where RWE can be useful, such as in postmarket surveillance studies and as supplementary data for case reports and adverse event reports, among other areas.
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