An American Sickness: How Healthcare Became Big Business and How You Can Take It Back

by Elisabeth Rosenthal

In 1976, amendments to the 1938 Food, Drug, and Cosmetic Act defined three different classes of devices that needed various levels of approval to ensure their effectiveness and safety before sale. Class 1 included equipment like tongue depressors that required little if any scrutiny. Devices whose impact was “life-threatening or life sustaining” or that “present[ed] unreasonable risk of illness or injury, and required extensive testing,” such as pacemakers, were included in class 3. Class 2 devices were those in between, which were governed by a new program called 510(k). To gain access to the market via the 510(k) route, companies had only to claim that their new device was “substantially equivalent” to a product already sold in the United States and used for the same purpose. The program defined “substantially equivalent” in vague terms that device company lawyers would come to love and exploit: “Not intended to be so narrow as to refer only to devices that are identical to marketed devices, nor so broad as to refer to devices which are intended to be used for the same purposes as marketed products.” The boundaries of the three device categories seemed easier to define four decades ago, and the government likely never anticipated a world in which those categories would be gamed for profit. The revolutionary Starr-Edwards heart valve had a relatively simple ball-and-cage design. There was no microprocessor, no genetic engineering, no Internet. But as the device industry g...