THE FDA’S 510(k) APPROVAL PROCESS AND THE SAFETY OF MEDICAL DEVICES

Abstract

Innovation fuels American business. Commonly, innovation is judged as good. Yet, many of the new medical devices that come on the U.S. market every year are later deemed unsafe. Regulation is distorted in that 98% of medical devices are never evaluated in human trials before being introduced to the marketplace. Instead, the U.S. Food and Drug Administration (FDA) approves a new medical device through a designated 501(k) process, based upon the identification of a predicate or substantially equivalent (SE) device. This is an investigation of the tension between product innovation, government regulation, and public safety in the American healthcare industry. It is a research project in two parts. The first draws upon established methodologies and utilizes the FDA’s 501(k) database to provide an illustrated example of the sequence and dependency between generations of implanted surgical mesh devices. The analysis reveals that the 501(k) approval process reliance on predicate devices facilitates medical device innovation that is problematic in several aspects, including patient safety. To further examine medical device innovation and patient safety, the second study develops a proof-of-concept exercise to evaluate data on recorded adverse events (AEs) found in the FDA’s Total Product Lifecyle (TPLC) database for surgical mesh products. The adverse events were mapped to the Association for the Advancement of Automotive Medicine’s (AAAM’s) Abbreviate Injury Scale (AIS), following precedents found in the medico-legal literature and military injury biomechanics standards. This approach forges a path forward to determine the relative frequency and severity of adverse events of a specific medical device, compared to that of the overall FDA product category. These two research projects combine to contribute to the understanding of safety of the FDA’s approval process and by extension the medical device industry’s innovation practices.