Devices

Real-World Evidence Guidance Out

FDA has issued a draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, to clarify how the agency uses real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in medical device regulatory decision-making. The document defines real-world data as data collected from sources outside of traditional clinical trials and defines real-world evidence as evidence derived from aggregation and analysis of real-world data elements.

“This guidance should not be interpreted to convey that FDA is changing the evidentiary standards used in regulatory decision-making,” the guidance says. “Rather, this guidance describes the circumstances under which real-world data may be used in different FDA contexts based on the existing evidentiary standards.”

The document also clarifies when an IDE may be needed to prospectively collect and use real-world data for purposes of determining the safety and effectiveness of a device. But FDA says it does not address the use of non-clinical data, adverse event reports, and secondary use of clinical trial data. It also does not provide guidance about good study design methods, conduct, or statistical methodology.

Contents include an introduction and scope, background, real-world evidence, regulatory context in which real-world evidence may be used, characteristics of real-world data, examples where real-world evidence can be useful, and a glossary.

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