The Competitive Enterprise Institute appreciates the opportunity to submit these comments regarding the Institute of Medicine report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.” The medical device industry has been a remarkable private enterprise success that has improved or extended the lives of millions of people. Unfortunately, the FDA’s inconsistent and often unpredictable management of the device clearance and premarket approval processes has been increasingly burdensome for the industry, and it is leading to an exodus of pioneering research and development from the United States to other countries. CEI therefore commends the Food and Drug Administration (FDA) for attempting to study the shortcomings in its management of the 510(k) clearance process.
Unfortunately, the Institute of Medicine (IOM) committee tasked with this investigation abdicated its duty in performing this important task. In large part, we believe that the IOM committee’s failure is based on a misunderstanding regarding the design and purpose of the device classification system, as well as the sufficiency of the regulatory controls to which devices in each class are subject.
The classification system created by the 1976 Amendments was intended to assign devices to the appropriate regulatory class and establish standards, or controls, for each class that would provide a reasonable assurance of safety and effectiveness. The 510(k) process does not rely solely on a substantial equivalence determination to assure safety and efficacy, as additional regulatory controls and performance standards still apply to Class II devices both before and after marketing. Nor was the 510(k) process intended to establish an independent safety or efficacy review process akin to premarket approval, because the regulatory controls associated with the classification system were thought sufficient to provide a reasonable assurance of safety and effectiveness.
No comprehensive review has questioned the sufficiency of these regulatory controls. Nor is there any evidence indicating that the 510(k) process systematically allows unsafe devices on the market. Indeed, the IOM report itself acknowledges that there is no reason to believe that any devices currently on the market are unsafe or ineffective, and that “their use in clinical practice provides at least some level of confidence” in their safety and effectiveness. The IOM report was therefore wrong to suggest that eliminating the 510(k) clearance process is necessary to ensure the safety and effectiveness of new medical devices. On the contrary, improvements in the FDA’s management of new medical device reviews should be sufficient to provide an adequate assurance of patient safety without adding to the already substantial burdens on device manufacturers.