FDA Releases Draft Guidance on Use of Real-World Evidence for Medical Devices

The Food and Drug Administration (FDA) has released a draft guidance document and is seeking comments on how real-world data (RWD) collected from outside the clinical trial process should be used when making pre- and postmarket decisions for medical devices.

The draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices,” is a “cornerstone of our strategic priority of creating a national evaluation system for medical devices,” the FDA wrote in an email. “That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.”

The use of RWD, and the real-world evidence (RWE) derived from aggregating it, can help improve the understanding of medical device risks and benefits, the guidance said, and is part of the FDA’s efforts to balance safety with the availability of new device technology. However, data collected from clinical environments may not have the same data quality controls as clinical trials. To that end, the FDA said it will assess the “relevance and reliability” of the data source to determine whether it is “reliable, complete, consistent, accurate, and contains all critical data elements necessary for evaluating the performance of a device in the applied regulatory context.”

The FDA said the new guidance will not change its standards for making regulatory decisions. However, the FDA said it will “consider the use of RWE to support regulatory decision-making for medical devices when it concludes that the clinical data contained within RWD sources(s) used to generate the RWE are of sufficient quality to provide confidence in the analyses necessary to inform or support the regulatory decision throughout the total product life cycle. The threshold for sufficient quality will depend on the specific regulatory use of the evidence.”

Marilyn Neder Flack, vice president of patient safety initiatives and executive director of the AAMI Foundation, said she’s pleased that the draft guidance includes the flexibility to determine when real-world data should be used, given the benefits and risks for a particular device.

Comments can be submitted online at www.regulations.gov until Oct. 25.