RWD/RWE for Medical Device Submissions is Subject of FDA Draft Guidance

How the FDA evaluates real world data (RWD) to determine if they are of sufficient quality to be used as real world evidence (RWE) in regulatory decision making for medical devices is the subject of an FDA draft guidance that will replace a previous guidance on the topic issued in 2017.

The 39-page guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” includes sections on general considerations for the use of RWE, how the FDA will assess data relevance and reliability, the agency’s consideration of how RWD is collected and analyzed to be used as RWE and documentation needed for FDA review.

The guidance also includes a table listing FDA expectations of data elements sponsors should expect to document and where to provide that information in an FDA submission. Comments on the draft are due by Feb. 19, 2024.

Read the draft guidance here.

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