The Food and Drug Administration said Monday that pelvic mesh will now be considered a class III, or high-risk, medical device, and manufacturers will be required to submit premarket approval ...

While the FDA previously required companies to have explanatory text accompany any standalone labels, pressure from the medical device industry — who saw the old method as inefficient — pushed ...

Drug and medical device makers ... a wide variety of information available to them about the way off-label drugs and devices work, including studies in journals, Clinical Practice Guidelines ...

The FDA says the labels on some EpiPen and EpiPen Jr. auto-injectors, including authorized generic versions, might prevent the device from easily sliding out of their carrier tubes. It could mean ...