Post-Market Approval Surveillance

he availability of new therapies over the past 2 decades has dramatically changed the practice of medicine.The introduction of medical devices has ushered in the era of minimally invasive procedures, thus fundamentally changing many surgical disciplines and creating new sub-specialties.Nowhere has the impact of new device technology been more dramatic than in the discipline of interventional cardiology.In addition to driving the growth of the medical device industry, device development has spawned entire new industries devoted to the coordination and administration of clinical trials.For a company to market a new high-risk device in the United States it must obtain approval from the Food and Drug Administration (FDA) based on the ability to demonstrate safety and effectiveness. 1 For a new interventional device like a drug-eluting stent, this is typically accomplished by performing large, multicentered, randomized controlled studies.These studies are performed by clinical investigators at research institutions on highly selected patients that may represent a small sector of the population for which the device is being developed.FDA approval is typically limited to the patient population studied, which is specifically outlined in the package labeling and instructions for use.Nevertheless, it is generally understood that after market release, devices are commonly used outside the narrow confines of the pivotal study's selection criteria by operators with a wide spectrum of training and experience at institutions lacking the infrastructure or competency of the research institutions where the pivotal trials were performed.It is assumed that the benefits of device use demonstrated in the pivotal trials can be generalized to a wider patient population in the general clinical community.Whereas large resources have been devoted to the early development and clinical evaluation of new medical devices, few resources have been focused on post-market surveillance, which is the systematic evaluation of these therapies after FDA approval.The Dartmouth Device & Drug Development Symposium was held in October 2003 with joint inventor, entrepreneur, industry, clinical, and regulatory participation, in an effort to characterize the process by which new interventional devices are currently developed and approved.One focus of the symposium was the role of post-market surveillance. The Current LandscapeMedical devices are regulated in the United States by the Center for Device and Radiologic Health (CDRH) of the Food and Drug Administration.In addition to its role in the evaluation of new devices, the FDA/CDRH charter includes the regulation of devices after approval.Currently, this function has been carriedThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.