FDA finalizes guidance on the use of real-world data to regulate medical devices

The Food and Drug Administration is moving forward with a novel approach to use data housed in EHRs, health registries and insurance claims to inform its analysis of innovative medical devices and technology.

The FDA posted a notice to the Federal Register on Wednesday announcing the availability of the new guidelines. Recognizing both the value and limitations of real-world data (RWD) collected during clinical care, the FDA acknowledged that “in certain circumstances RWD may be of sufficient quality to help inform or augment FDA’s understanding of the benefit-risk profile of devices at various points in their life cycle.”


Originally issued in July 2016, the finalized guidelines note that the FDA “does not endorse one type of RWD over another,” nor does it aim to mandate or restrict the use of RWD. Instead, the agency directs manufacturers to tap data sources based on accuracy and whether they can address specific regulatory questions.  

But the agency also acknowledged the wide-ranging situations in which RWD may be valuable, making it difficult to construct specific definitions and use cases. Data leveraged from a health registry, for example, may be suitable for postmarket surveillance, but inadequate to assist with premarket approval.

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“Devices are often used in routine clinical practice for uses that are not within their cleared or approved indications for use,” the guidelines state. “However, the knowledge gained from all uses of a device in medical practice is often not realized because the data collected are not systematically characterized, aggregated, and analyzed in a way that can be relied upon to inform regulatory decision-making. By recognizing the value of RWE as an important contributing factor for understanding and regulating medical devices, we hope to encourage the medical community to learn more from routine clinical care than we do today.”

The guidelines are another step in the FDA’s quest to incorporate vast amounts of healthcare data into its regulatory process. Last week, officials with the FDA outlined the tremendous potential of data buried in EHRs and medical claims, but defining it continues to be a challenge.

The approach could be a boon for health IT systems that require FDA approval. The FDA user fee reauthorization bill that was recently signed into law by President Donald Trump includes funding for a National Evaluation System for health Technology (NEST) to leverage RWD to quickly identify safety concerns reduce the time and cost of approval for cutting edge medical technology.