FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also provides expanded recommendations to sponsors considering using real-world evidence to support a regulatory submission for medical devices.
The Draft Guidance outlines the key factors to consider when assessing the quality and suitability of RWD for specific regulatory purposes. The guidance also offers recommendations for sponsors seeking to incorporate RWD into their regulatory submissions. Regardless of the RWD source, the guidance applies broadly and encompasses the processes involved in conducting studies to generate RWE.
This draft guidance also proposes expanded recommendations to the 2017 guidance “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. The 2017 final guidance remains in effect until this draft guidance is finalized.