In a recent article published in the New England Journal of Medicine, FDA confirms in the future computer-based modeling may change the way we think about device validation.
This article, written by Owen Faris and Jeff Shuren from the US Food and Drug Administrations, presents the FDA view point on medical device clinical trials and refers to the use of modeling and bench tests to inform clinical studies.
Higher-risk and innovative moderate-risk devices (approximately 4% of all medical devices), generally require clinical evidence to show that the benefits of a technology outweigh its risks. Such information is often critical not only for showing the safety and effectiveness of the device but also for informing clinicians and patients about the preferred use of the device in the marketed clinical setting.
The article illustrates the array of trial designs and clinical data sources that may be used to support the safety and effectiveness of these critical products and refers to the Medtronic Revo MRI pacemaker system as a success study that confirms how modeling data can provide strong reliable evidences during the validation phase of a new device.
As stated in the article, thanks to these successful results, computer-based modeling may change the way we think about device validation.
The full article is available here.