Medical Devices

Medical devices play a critical role in the health care of older Americans. Items classified as medical devices include a wide array of products ranging from tongue depressors to heart valves. The Food and Drug Administration (FDA) is responsible for pre-market review, clearance and approval, post-market surveillance, investigation of adverse-event reports, inspections, and enforcement. 

The FDA requires that “high-risk” medical devices undergo pre-market approval, a rigorous process involving clinical trials to determine safety and efficacy. However, low- and moderate-risk devices can receive FDA clearance through an administrative review of a paper application, known as the 510(k) process. This relies on the concept of “substantial equivalence” to determine whether new devices are similar enough to comparable devices that were already cleared or on the market before 1976 when the first medical device law was enacted. But reliance on substantial equivalence cannot ensure that devices reaching the market are safe and effective since most devices used as the basis for comparison were never reviewed for safety and effectiveness. In some cases, devices that the FDA has recalled for safety reasons have been used by manufacturers to gain clearance for similar devices based on substantial equivalence. The FDA has stated that it lacks authority to address this problem. 

Manufacturers are permitted to market devices only for specific indications approved by the FDA. However under the “practice of medicine” exception, doctors may use any approved device for other non-approved indications. This is referred to as “off-label” use. For example, a surgeon may implant a stent—a device approved by the FDA only for coronary arteries—to prop open other non-coronary arteries. 

Estimates of the frequency of severe injuries and deaths associated with medical devices vary. The FDA has required reporting of medical device problems since 1990. However, data collected in this manner have been criticized as incomplete, untimely, and not readily accessible. In addition, the FDA requires manufacturers to track certain medical devices that are implantable, life-supporting, or life-sustaining to facilitate patient notification and recall. That monitoring is performed by the device manufacturer, and the information is not readily available to the FDA. Further, this monitoring activity rarely extends beyond three years, even though most of these devices are designed to last much longer. In order to improve reporting of post-market adverse events, facilitate device recalls, and reduce medical errors, many countries require that a unique identifier be assigned to high-risk medical devices and listed in the country’s national device registry. 

The Supreme Court has held that medical device makers are immune from liability for personal injuries as long as the device has been approved by the FDA using its most rigorous review standard. This standard is known as the pre-market approval process. Devices cleared through this process are typically higher risk, such as implantable pacemakers and heart valves. Although devices that are shielded from liability represent only a small proportion of medical devices, about ten million people, most of them older than age 65, could be affected by limitations on manufacturer liability for defective medical devices. In its opinion, the Supreme Court left open the possibility that similar protection from liability could be extended to drug manufacturers. 

In 2012, Congress directed the agency to implement a unique device identification system for high-risk devices and extend its post-market risk identification and evaluation system to include medical devices.