The Food and Drug Administration (FDA) recently published draft guidance on the use of real world evidence (RWE) for medical devices. This guidance follows the earlier recommendations to the industry on the use of RWE for biological products published in August 2023. These guidance documents over the last year indicate both the importance of RWE to support regulatory approvals, but also the increase in its use cases.

The recent medical device guidance encourages companies to leverage RWE for a number of use cases, such as learning about patient experience, identifying target population, providing longer follow-up vs. clinical studies, historical or concurrent control groups, supporting artificial intelligence/machine learning-enabled devices, and informing risk-benefit assessments which are not feasible in clinical trials. It is clear that RWE is positioned as a useful tool to support with device innovation.

When comparing the medical device guidance to the biological guidance, it is encouraging to see consistency in FDA recommendations. Most importantly, the FDA encourages:

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