Device Makers Get Updated Guidance on Use of Real-World Data

The FDA released a draft guidance for medical device manufacturers Tuesday to clarify how the agency evaluates real-world data and real-world evidence in making decisions about devices submitted for approval.

The draft guidance includes the relevance and reliability factors that the Food and Drug Administration considers important to demonstrate whether the real-world data—derived from electronic health records, medical claims, product and disease registries, and sources such as digital health technologies—are of sufficient quality to generate real-world evidence fit to support FDA decision-making on manufacturers’ submissions.

Real-world evidence is the clinical evidence regarding the usage, and potential benefits or risks, of ...