FDA Regulation and Approval of Medical Device...

Idiosyncratic drug-induced liver injury is damage caused by prescription or over-the-counter medications or herbal dietary supplements that is not dose-dependent. JAMA Associate Editor Beverly Forsyth, MD, speaks with author Naga Chalasani, MD, of Indiana University School of Med ...  Show more

Childhood obesity affects approximately 15% of children aged 2 to 12 and is associated with adverse health outcomes in adulthood. Author Claudia K. Fox, MD, MPH, of the University of Minnesota Medical School joins JAMA Deputy Editor Mary M. McDermott, MD, to discuss epidemiology, ...  Show more

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regula ...  Show more

If you're like many in the medical device industry, you've probably had some questions at one time or another around the FDA's Design Control Guidance. And if you're anything like the guests on today's podcast, you've probably gone through a lot of trial and error trying to imple ...  Show more

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device ind ...  Show more