The U.S. Food and Drug Administration (FDA) recently proposed a new way to fast-track medical devices to the market. Scott Gottlieb, Commissioner of the FDA, proposed making a quicker route to market for certain products that might not meet the current criteria for clearance under the agency’s 510(k) fast-track pathway. Gottlieb’s reasoning for the proposal is that it would foster innovation. This ...
Early last week we were shocked and saddened at the tragic loss of at least 25 men in a West Virginia mine. We subsequently learned that the mine was cited more than 50 times in the last month alone for uncorrected safety violations. 12 citations were for problems with ventilation and preventing methane gas buildup. Mining has always been dangerous and some accidents may be unavoidable. But if ...