(From Regulatory Focus, February 16, 2018)
Experts See Promise, Risk in Relying on Real World Evidence for Medical Devices
by Michael Mezher
In a perspective published in the New England Journal of Medicine on Thursday, two medical device experts argue that real-world evidence (RWE) could be used to answer many questions about the safety and effectiveness of medical devices, but caution that RWE may not be appropriate for initial marketing decisions.
Background: Real World Evidence
In recent years, the US Food and Drug Administration (FDA) has worked to expand the use of RWE, such as electronic health records (EHRs), insurance claims data and information from patient registries, to improve its postmarket surveillance capabilities as well as in its decision-making for medical products.
Last August, the agency finalized guidance on using RWE to support the approval or clearance of medical devices.
Congress has also pressed FDA to incorporate RWE into its oversight of medical products in both the 21st Century Cures Act and the FDA Reauthorization Act.
RWE: Pre- and Postmarket Use
In their article, Frederic Resnic, chairman of the Department of Cardiovascular Medicine at the Lahey Hospital and Medical Center, and Michael Matheny, director of the Center for Population Health Informatics at Vanderbilt University Medical Center, argue that for now, RWE is most useful in the postmarket setting...