IOM: 510(k) does not ensure device safety, effectiveness
Members of the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process defend the findings of its recently released report—which recommended the FDA scrap its 510(k) process and start afresh—in a perspective published Aug. 10 in the New England Journal of Medicine.
“After careful study, we concluded that the time has come for a forward-looking regulatory system, rather than one that focuses on past products,” write David R. Challoner, MD, vice president of health affairs at the University of Florida, and William W. Vodra, JD, former senior counsel, Arnold and Porter, both members of the IOM committee.
The current law allows medical devices to enter the market based on a “substantial equivalent” that was previously cleared. “The underlying assumption is that if a new device is equivalent to a previous similar device, it will be at least as safe and effective as that device,” the authors wrote.
However, allowing a product to enter the market based on the equivalency of a previously cleared device is problematic, according to the authors, because it doesn’t ensure safety and effectiveness.
“Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing two years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976,” wrote Challoner and Vodra. “But that original device might never have been assessed for safety and effectiveness, nor perhaps would any subsequent ones in the family tree.”
Additionally, the authors offered, a novel device that does not have a substantial equivalent on the market can be cleared if it has various characteristics that are identical to traits of different previously cleared devices, even though the prior devices may not be on the market. “So there may be no real-world experience to provide a basis for assessing safety or effectiveness—even if we had a high-quality postmarketing surveillance system to capture this experience.”
The committee recommended a new regulatory framework for moderate-risk devices, but didn’t detail what that framework should be. The FDA needs to obtain adequate information, which does not currently exist, to inform the design of the new framework, wrote the authors. “The report does, however, include a list of ideal attributes of the framework, indicating that the process should be based on sound science; be clear, predictable, straightforward and fair, be self-sustaining and self-improving” and possess other atttributes that the authors laid out.
Additionally, a premarket review is not sufficient to ensure the safety and effectiveness of a device, they argue. “Adequate postmarketing oversight is also necessary for a comprehensive regulatory framework, and today’s FDA confronts substantial deficiencies in this area. … The FDA has also lacked a system of continuous quality improvement for its device program.”
Challoner and Vodra recommended that the FDA commission a study to assess whether the regulatory process for Class II medical devices facilitates or inhibits innovation in the industry. While the authors note that the FDA has worked to improve some processes, they call on the administration to work with the medical device industry, consumers, providers, payors and Congress to design a new regulatory framework.
“Each year, several thousand devices—about one-third of devices entering the market—are cleared through the 510(k) process. Although the continuous use of many of these devices in clinical practice provides a level of confidence in their safety and effectiveness, what patients want is reasonable assurance that a device is clinically effective and that its benefits outweigh its risks—not merely an indication that is it substantially equivalent to another devices,” Challoner and Vodra concluded. “The 510(k) process cannot provide that assurance. Now is the time to move forward with designing a comprehensive regulatory framework for the next 35 years and beyond.”
“After careful study, we concluded that the time has come for a forward-looking regulatory system, rather than one that focuses on past products,” write David R. Challoner, MD, vice president of health affairs at the University of Florida, and William W. Vodra, JD, former senior counsel, Arnold and Porter, both members of the IOM committee.
The current law allows medical devices to enter the market based on a “substantial equivalent” that was previously cleared. “The underlying assumption is that if a new device is equivalent to a previous similar device, it will be at least as safe and effective as that device,” the authors wrote.
However, allowing a product to enter the market based on the equivalency of a previously cleared device is problematic, according to the authors, because it doesn’t ensure safety and effectiveness.
“Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing two years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976,” wrote Challoner and Vodra. “But that original device might never have been assessed for safety and effectiveness, nor perhaps would any subsequent ones in the family tree.”
Additionally, the authors offered, a novel device that does not have a substantial equivalent on the market can be cleared if it has various characteristics that are identical to traits of different previously cleared devices, even though the prior devices may not be on the market. “So there may be no real-world experience to provide a basis for assessing safety or effectiveness—even if we had a high-quality postmarketing surveillance system to capture this experience.”
The committee recommended a new regulatory framework for moderate-risk devices, but didn’t detail what that framework should be. The FDA needs to obtain adequate information, which does not currently exist, to inform the design of the new framework, wrote the authors. “The report does, however, include a list of ideal attributes of the framework, indicating that the process should be based on sound science; be clear, predictable, straightforward and fair, be self-sustaining and self-improving” and possess other atttributes that the authors laid out.
Additionally, a premarket review is not sufficient to ensure the safety and effectiveness of a device, they argue. “Adequate postmarketing oversight is also necessary for a comprehensive regulatory framework, and today’s FDA confronts substantial deficiencies in this area. … The FDA has also lacked a system of continuous quality improvement for its device program.”
Challoner and Vodra recommended that the FDA commission a study to assess whether the regulatory process for Class II medical devices facilitates or inhibits innovation in the industry. While the authors note that the FDA has worked to improve some processes, they call on the administration to work with the medical device industry, consumers, providers, payors and Congress to design a new regulatory framework.
“Each year, several thousand devices—about one-third of devices entering the market—are cleared through the 510(k) process. Although the continuous use of many of these devices in clinical practice provides a level of confidence in their safety and effectiveness, what patients want is reasonable assurance that a device is clinically effective and that its benefits outweigh its risks—not merely an indication that is it substantially equivalent to another devices,” Challoner and Vodra concluded. “The 510(k) process cannot provide that assurance. Now is the time to move forward with designing a comprehensive regulatory framework for the next 35 years and beyond.”