JD Supra

FDA's Guidance on the Use of Real-World Evidence for Medical Devices

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...
Forbes

Disappearing Evidence—Why Your Phone Can’t Wait For Forensics

Forbes contributors publish independent expert analyses and insights. Lars Daniel covers digital evidence and forensics in life and law. Our smartphones hold the keys to our digital lives. Preserving ...
MobiHealthNews

FDA looking into real-world evidence for device evaluation

When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show ...
Forbes

Digital Forensics—What Exactly Is Digital Evidence?

Forbes contributors publish independent expert analyses and insights. Lars Daniel covers digital evidence and forensics in life and law. In the quiet heart of Wichita, Kansas, a chilling shadow ...
Health Affairs

FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies

The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment ...