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Medical imaging and radiation therapy technology have revolutionized the diagnosis and treatment of disease over the course of the last century. Medical imaging and radiotherapy manufacturers are engaged in a continuous, incremental process of adding new features and advancing technological characteristics to improve patient outcomes.
While the fundamental technology of imaging remains clinically relevant, each generation of imaging devices enhances physicians' ability to detect, stage, and treat disease. Due to continuous innovations, imaging device lifecycles are often only one to two years, making a consistent, predictable, and efficient review process essential to ensure that patients have access to the most advanced medical technology available. The Food and Drug Administration's (FDA) 510(k) review process has stood the test of time in ensuring safety, while increasing patient access to these innovative medical devices.
The 510(k) review process was originally created by Congress in 1976 to ensure only safe and effective devices are available for use in the U.S. The process is based on demonstrating that a product is "substantially equivalent" to another product, or "predicate," already on the market.
Over the years, as decades of devices have been cleared through the review process, FDA critics began making claims about dangerous devices having been approved through 510(k) because they distantly resemble products approved decades ago.
The FDA took an initial step in addressing these concerns two years ago by commissioning the Institute of Medicine (IOM) to evaluate and recommend ways to improve the government's system for approving medical devices through the 510(k) process by assessing its ability to protect patients and foster innovation.
While the IOM committee convened, the FDA began actively working with industry, physicians, patient groups, and other stakeholders to collaboratively review the process and discuss potential changes. FDA has issued reports and published new standard operating procedures, guidances, and regulations, and the Medical Imaging & Technology Alliance (MITA) is one of a few leading groups that provided detailed and comprehensive comments as an active participant in the reform effort.
The imaging community has been deeply involved in the 510(k) reform effort with the FDA over the past year and was surprised in late July when the IOM report was finally released. To our disappointment, the 12-member committee recommended an unrealistic and unnecessary solution: abandon the current device clearance process and design an entirely new regulatory framework that includes both premarket and post-market surveillance.
IOM's recommendations were already coming very late in the process, but it was even more concerning that they fell so far outside of the current conversation. All of the FDA and imaging community's efforts to identify and implement targeted and effective improvements to the 510(k) review process would effectively go to waste if the system is abandoned.
 Additionally, IOM's recommendations would stifle product development and add uncertainty to reviews that are already increasingly slow and unpredictable. Approving such a radical change would inhibit innovative technology from reaching patients due to requirements for extensively more clinical data for technology that's already widely known.
Not only did the committee ignore making recommendations regarding the FDA's question on innovation, but IOM itself also admitted to criticizing the 510(k) system without any data that 510(k) cleared products are unsafe. The report also stated that continued use of cleared devices provides reason for "a level of confidence in their safety and effectiveness."
In fact, recent studies have demonstrated that the 510(k) process is extremely successful in the protection of public health, with less than 0.5 percent becoming the subject of a Class I safety recall, the FDA's most serious recall category, often due to post-marketing quality system issues, not premarket approval.
When American jobs and patient access to lifesaving technologies are at stake, it is vitally important that reforms to the 510(k) process be based on a complete understanding of all aspects of the advanced medical devices, including manufacturing and the clearance process itself, as opposed to ad hoc criticisms. The immediate need is for the FDA to build on the current 510(k) process by implementing reforms that further promote innovation, enhance regulatory predictability, improve timeliness, and protect public health.
The proven 510(k) program continues to evolve and bring safe and effective products to market. However, the program is not perfect and needs to address a number of important areas, specifically the transparency of decision-making, slowing timeliness and changing requirements. Given the number of changes to the 510(k) process already proposed by the FDA, the IOM report must be carefully evaluated in a critical dialogue between industry, the FDA, and other stakeholders to ensure that only those changes that will truly balance innovation and the safety of the general public are ultimately implemented. MITA remains committed to working with the FDA and Congress to achieve these goals.
Dave Fisher is executive director of the Medical Imaging & Technology Alliance (MITA), a division of the Association for Electrical & Medical Imaging Manufacturers. MITA is the collective voice of medical imaging and therapy equipment manufacturers, innovators, and product developers. For more information, visit www.medicalimaging.org.
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