FDA Cleared vs. FDA Approved: Why the 510(k) System Is Broken and How Medical Device Manufacturers Can Reduce Risk
Nearly every day, the public is bombarded with stories of medical device failures. There was the recall of 6 million defective endotracheal tubes used to keep patients breathing during surgery. Or, how about the FDA’s total shutdown of pelvic mesh sales after discovering that the concept didn’t translate well from similar-but-different hernia mesh, instead causing bleeding, infection and even punctured organs in some patients. Maybe you heard about the duodenoscopes used extensively for diagnosing and treating upper digestive tract problems that have sickened hundreds of patients and can even transmit antibiotic-resistant superbugs, that was reported by the New York Times.