Researchers at the Stanford University Program in Biodesign have released a review of the background, mission, and statutory requirements of medical device regulation in the United States. The report highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA).
According to the researchers, regulation plays a key role in the design, development, and commercialization of new medical technologies, making a comprehensive understanding of the various regulatory requirements and their practical implementation a cornerstone of successful medical device innovation. The major barriers to moving innovative technologies from the bench to the bedside in the safest and most efficient way stem from the lack of precise scientifically based data about testing, regulatory approval, and health-economic evaluation processes.
The review is part of an ongoing project at Stanford to examine how medical technology is brought to market, approved for use, and subsequently enhanced over time. A key goal of the research is to build a model specific to medical technology that will be of value to current and future government initiatives aimed at enhancing the efficiency and efficacy of the regulatory process for public benefit.
“Over the last couple of years, highly publicized recalls of medical devices – such as defibrillators and pacemakers – have sparked internal debate within the FDA about ways to improve post-market surveillance and adverse event reporting,” said Jan B. Pietzsch, Ph.D. (pictured), Consulting Assistant Professor in the Department of Management Science and Engineering at Stanford. “By thoroughly mapping the current regulatory process, we can contribute to understanding the entire complex process of medical device innovation and how it can be improved for manufacturers, and more importantly, for patients.”
The FDA’s Center for Devices and Radiological Health (CDRH) is currently taking steps to improve the post-market surveillance, researchers note, including strengthening the condition of approval studies; improving medical device reporting; focusing on risk-based inspections; implementing third-party inspections; communicating risk/benefit information; and refining the FDA’s communications strategy.
In contrast to pharmaceuticals, medical devices are evaluated using a risk-based classification system that determines its regulatory pathway. Devices are placed into one of three classes: Class I devices, representing low-risk items such as examination gloves, do not require performance standards; medium and high-risk devices (Classes II and III) such as infusion pumps and defibrillators, follow specific regulatory requirements that vary substantially.
By using a risk-based system, said researchers, the FDA recognizes that some degree of risk is inherent in the development of devices, and further, that all hazards cannot be eliminated. There is often little or no prior experience on which to base judgments about safety and effectiveness; devices undergo performance improvement modifications during clinical trials; and results depend on the skill of the user.
Other key points from the review include:
-Class III devices are subject to the most stringent controls and require pre-market approval (PMA) to ensure safety and effectiveness of the devices.
-The PMA program and 510(K) pre-market notification program resemble the “regulatory pathways” often referred to by industry.
-The FDA quality systems regulations (QSR) define in clear terms the specific requirements manufacturers need to follow in design, testing, manufacturing, and post-market surveillance of medical devices.
-Manufacturers have specific timeframes in which to report adverse events: 5 calendar days for device-related death, serious injury, or malfunction requiring immediate action; 30 days if no immediate action is required.
-The medical device reporting system is in the process of being improved through the development of electronic reporting tools, making it easier for manufacturers to relay potential problems.
-Increased harmonization of international standards between the U.S., the European Union, Australia, Brazil, and Canada are intended to improve the integration of medical device product safety and process quality on a global basis.
Illustration: Stanford University, Department of Management Science and Engineering.
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Abstract (Journal of Medical Devices, December 2007, Volume 1, Issue 4, pp. 283-292)