1976

Amendments to 1938 Food, Drug, and Cosmetics Act establish three classes of medical/surgical devices requiring different levels of approval to ensure safety and effectiveness: Class 1 = simple devices like tongue depressors requiring little if any scrutiny; Class 3 = devices with “life-threatening or life sustaining” impact and attendant risks (e.g., pacemakers) extensive testing; and Class 2 = intermediate type devices to be governed by the 510(k) program, under which “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, not so broad as to refer to devices which are intended to be used for the same purposes as marketed products’.” Class 2 clearance quickly became the fast track to profitability for device manufacturers, as the FDA spent about 20 hours evaluating 510(k) requests compared with 1,200 hours for class 3 devices. “Suddenly, most applications were submitted as class 2 products,” with the surprising results “that today there is generally far less careful scrutiny of new devices than of new drugs” (Rosenthal, 132-133).