Medical Devices

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Medical devices occupy a prominent position in health care and among health-related products. According to reports from 2017 and 2018, more than 18,000 manufacturers produce an estimated 190,000 distinct medical devices that are regulated by the U.S. Food and Drug Administration (FDA). Spending on medical devices in the US was estimated at $173 billion in 2019, up from an estimated $36 billion (in 2019 dollars) in 1983. The medical device industry is regulated primarily under a framework established by the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetics Act of 1938. Because of rapid technological advances since 1976, the U.S. Congress and the FDA modified regulatory standards to minimize unnecessary requirements, promote the availability of innovative devices, and fulfill the agency’s mission as steward of the public’s health. The COVID-19 pandemic has contributed to a renewed focus on the assessment of medical devices and tests.

In the early 20th century, some manufacturers made fantastic and inadequately supported claims about the curative powers of their medical devices. This led Congress in 1938 to take action against mislabeling of devices, but there was no provision for premarket review. Recognizing the need for greater regulation, Congress provided the FDA with premarket review authority in the Medical Device Amendments of 1976. This broadly defined devices to include any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article” designed for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body, that does not achieve its effect through chemical action.

The 1976 legislation created a risk-based classification system that subjected different kinds of devices to graded levels of regulation. Low risk, class I devices, such as stethoscopes and bandages, were subject to “general controls,” such as requirements to follow good manufacturing standards and prohibitions against adulteration and misbranding. Moderate risk, class II devices, such as surgical mesh, ventilators, powered wheelchairs, and joint replacement implants, were subject to performance standards, such as the requirement that a colonic capsule endoscopy system can withstand a range of pH values. Many infection-related diagnostic tests are also categorized in class II, such as those to detect TB, dengue fever, and cholera.

High risk, class III devices, such as pacemakers, implantable eye lenses, and breast implants, were subject to premarket approval application (PMA) requirements involving full reports of scientific investigations that provided reasonable assurance of safety and effectiveness.

In 1997, the FDA Modernization Act directed the FDA to consider whether premarket data requirements could be “reduced through reliance of postmarket controls”, such as surveillance during clinical use. It takes time to get a new device approved for general use. The average time from submission of an application to PMA approval varies from 300 to 1000 days. Over the past 45 years, as medical devices have become more complex, so too has their approval for use and regulation. Inevitably, some tension has arisen between industry and flexible authorization requirements, but the goal of the FDA is to assure that medical devices are both safe and will benefit patients.

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By Peter Galvin, MD

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