Global Medical Device Podcast Powered By Greenlight.guru

Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process.In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and how to navigate this process in an efficient and compliant manner.Some highlights of this episode include:FDA has a few programs to consider when it comes to safety and significant risk or not for products. High-risk devices could fall into a non-significant risk study.Exempt or not? Make sure to provide sufficient information to identify significant or not risks based on objective evidence. COVID-19 issues prompted FDA to post guidance on statistical considerations, confounding factors, and remote monitoring for