Pharmaceutical Regulatory Affairs: Open Access

FDA Regulation of Medical Devices and Medical Device Reporting

Abstract

Teow N and Siegel SJ

There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to identify the major areas of focus in medical device regulation according to industry, regulators, and practitioners, and to investigate the feasibility of increased practitioner participation in medical device reporting. The author interviewed 5 industry, 5 regulators, and 6 practitioners. The stakeholders’ views were influenced by their personal distribution on the importance of outcomes such as cost, speed, safety and effectiveness. Industry, regulators and practitioners’ main perspectives were that medical device regulation is inconsistent and unpredictable, and that the US medical device industry is lagging behind Europe. Individual stakeholder goals were not aligned and caused bias resulting in a varied depiction of FDA regulation of medical devices. A practitioner-focused survey on medical device reporting was sent to 1567 practitioners in the University of Pennsylvania Health System. 340 survey responses showed that 46% of practitioners have witnessed a medical device failure, but only 19% have ever filed a medical device report. The survey results revealed that practitioners do not currently have enough experience or knowledge about medical device reporting to participate effectively and positively impact postmarket surveillance.