Let’s just say that airplane and medical device manufacturers have “substantially equivalent” problems. The crisis over the 737 Max tells us why.Ashley Holub (Twitter @ashtroid22)
From Netflix’s documentary “The Bleeding Edge” to the International Consortium of Investigative Journalists’ “The Implant Files” series, FDA has taken heat over the 510(k),which allows devices with “substantially equivalent” features to previously approved technology to go through a less strenuous review.The saga over Boeing’ 737 Max and the Federal Aviation Administration’s handling of it has a striking resemblance to another government controversy: the criticism FDA has received over its 510(k) medical device clearances.
Meanwhile, FAA has faced similar fault-finding when it comes to Boeing 737’s Max 8. Initially announced in 2011, the Max was delivered with promises of improved fuel and economic efficiency. But less than a year and a half after its first flight the 737 Max 8 crashed in Indonesia, killing all 189 people on board. Just five months later, the Max crashed again, in Ethiopia, accounting for a total of 346 lost lives. The two crashes represent a strong safety signal warranting further attention — raising questions that apply not only to airplanes but also to medical devices.