The past 5 years have ushered in major, much-needed changes in the oversight of medical devices in the United States. Although several efforts remain works in progress, the US Food and Drug Administration (FDA) is taking important steps to improve premarket device review and postmarket device surveillance.
The FDA’s framework for medical device regulation is complex, in no small part because of the great diversity of devices. The FDA has regulatory responsibility for a wide range of products, from simple and low-risk tools, such as crutches, to more complex and higher-risk devices, such as implantable cardioverter defibrillators. For all these products, the FDA must ensure an appropriate level of oversight sufficient to provide reasonable assurance that each device is safe and effective, but not so burdensome as to stifle the development of new, needed technological advances. This has long been a challenging balancing act. Regulation and oversight require attention to all stages of a device’s life span, from its pathway to market through its long-term use in medical practice.
Dietrich EM, Sharfstein JM. Improving Medical Device RegulationA Work in Progress. JAMA Intern Med. 2014;174(11):1779-1780. doi:10.1001/jamainternmed.2014.3211