FDA’s CDRH reviews 90 examples of regulatory submissions regarding medical devices supported by real-world evidence

The US FDA’s Center for Devices and Radiological Health (CDRH; MD, USA) has published an analysis of 90 examples of regulatory submissions regarding medical devices – made between 2012 and 2019 – that were supported by real-world evidence. The newly released analysis builds on the organization’s previously issued guidance in 2017, titled: ‘Use of real-world evidence to support regulatory decision-making for medical devices’, and aims to provide a more complete understanding of how real-world evidence can be used, to further its goal of fostering real-world evidence use in regulatory decision-making. In a blog post accompanying the published analysis, Jeff Shuren,...