Premarket Evaluation of High Risk Medical Devices in the EU
Recently the EU has come under heavy scrutiny for failing to produce adequate premarket clinical evidence that demonstrates efficacy and safety of innovative, higher – risk medic
Some IVDs and Radiology devices to be exempt from FDA 510(k)
The FDA (US Food and Drug Administration) has announced plans to ease the pre-market notification, or 510(k), requirements for certain in-vitro diagnostic (IVD) and radiology devic
