Now that the Institute of Medicine (IOM) has fulfilled its task of making recommendations for the 510(k) program at FDA, all parties have had a chance to respond to at least the broad strokes of the IOM recommendations. The long-awaited report recommends that FDA dump the 510(k) program and start over. However, while the suggestion has plenty of critics in industry, even FDA indicates it has no intention whatsoever of making such a move. (Medical Device Daily) Read More
