FDA has issued a draft guidance to clarify how they evaluate real-world data to determine whether it may be sufficiently relevant and reliable to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 FDA regulatory decision-making for medical devices.
generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices.
Real-World Data (RWD) is data collected from sources outside of traditional clinical trials. These sources may include large simple trials, or pragmatic clinical trials, prospective observational or registry studies, retrospective database studies, case reports, administrative and healthcare claims, electronic health records, data obtained as part of a public health investigation or routine public health surveillance, and registries (e.g., device, procedural, or disease registries). The data is typically derived from electronic systems used in health care delivery, data contained within medical devices, and/or in tracking patient experience during care, including in home-use settings.
Real-World Evidence (RWE) is the evidence derived from aggregation and analysis of RWD elements.
RWD and associated RWE could constitute valid scientific evidence, depending on the characteristics of the data. This guidance should not be interpreted to convey that FDA is changing the evidentiary standards used in regulatory decision-making; rather, this guidance describes the circumstances under which RWD may be used in different FDA contexts based on the existing evidentiary standards. This guidance also clarifies when an Investigational Device Exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of adevice. However, this guidance does not address the use of non-clinical data, adverse eventreports, and secondary use of clinical trial data (e.g., post hoc analyses). In addition, thisdocument does not provide guidance about good study design methods, conduct, or statisticalmethodology.