Postmarket surveillance for medical devices: America’s new strategy

In September 2012, the US Food and Drug Administration (FDA) released its vision for a postmarket surveillance system for medical devices,1 describing four key strategies to protect public health. But why this initiative now? Firstly, several concerns about the safety of specific devices, such as the Medtronic Fidelis defibrillator lead and the DePuy ASR hip implant, have garnered substantial press coverage.2 3 4 Secondly, the Institute of Medicine recently called for a substantial overhaul of processes for the approval and postmarket safety surveillance of medical devices.5 Thirdly, the FDA has undertaken several premarket initiatives to improve the efficiency of the regulatory review for innovative devices.6 With the number and complexity of medical devices growing rapidly, it is timely to complement the new premarket initiatives with a strong postmarket surveillance program.

Regulation of the entry into use of medical devices in the United States was introduced after that for drugs (table⇓), and it quickly became apparent that the public health assessment of devices would need to be different from that of drugs. Unlike drugs, medical devices are assembled from many components, may affect patients long after the initial exposure, and have rapid product development cycles, which lead to frequent incremental improvements. Medical devices also pose unique challenges to studying …