Compliance In Focus

On August 31, 2017 The Food and Drug Administration (FDA) issued the finalized guidance manual for medical device companies’ use of real-world evidence (RWE) and real-world data (RWD) to gain FDA approval for their medical devices. The FDA draft guidance was originally issued on July 27, 2016 to the public to give those in the medical device industry an opportunity to provide comments prior to finalization. Additionally, the FDA hosted a webinar on the topic to provide additional guidance on October 10, 2017. Per the FDA, the guidance was issued “to clarify how we evaluate RWD to determine whether it may be sufficiently relevant and reliable to generate the types of RWE that can be used in FDA regulatory decision-making for medical devices.” This includes whether or not FDA will require an Investigational Device Exemption (IDE) to determine the safety and effectiveness of a device.