On Monday, November 26th, the Food and Drug Administration announced they would be overhauling the most common process of medical device approval. In 2017, the FDA cleared 3,173 devices under the 510(K) process, or 82 percent of the total devices cleared or approved, Gottlieb and Shuren said in their statement to the press. “Data shows that nearly 20 percent of current 510(k)s...