The U.S. Food and Drug Administration’s certification of medical devices lacks the legal framework to be a “reliable premarket screen” and should be scrapped, according to the Institute of Medicine’s long-awaited 510(k) assessment.
Specifically, the IOM’s 510(k) report noted that the 510(k) approval process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.”
It asked the FDA to stop modifying or changing the way it reviews new innovative medical devices, and instead invest scarce resources to develop more robust “integrated premarket and post-market regulatory framework.”
At the same time, that the IOM panel found the 510(k) approval process inherently flawed, the committee noted that is not implying that “all, many, or even any medical devices cleared through the 510(k) process and currently on the market are unsafe or ineffective.”
In response to the IOM report, Jeffrey Shuren, director of the Center for Device and Radiological Health, appeared to be rejecting the main conclusion of the non-binding IOM report.
“FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs,” Shuren said in a news release Friday.
The FDA has been internally reviewing the 510(k) process and in January released a 25-step plan to overhaul the process. This week it issued the first draft guidance on when changes to a medical device may require a new submission.
Shuren’s was not alone in rejecting IOM’s call for abandoning the 510(k) process. In that regard, he was joined by the leading industry advocate — Stephen Ubl, president, Advanced Medical Technology Association, a group that has ironically been critical of how the FDA manages the 510(k) program.
“The report’s conclusions do not deserve serious consideration from the Congress or the Administration,” Ubl countered in the press release. “It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”
The industry has long argued that the 510(k) process has been historically a safe and effective way to introduce new innovative medical devices. The IOM report, however, could not conclude that the 510(k) process either inhibits or promotes innovation.
Along with the jettisoning of 510(k) process, the IOM committee also provided the concluded the following recommendations:
- FDA should develop and implement a comprehensive strategy to collect, analyze, and act on medical-device postmarket performance information
- FDA should review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed
- FDA should investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of Class II devices
- The Food and Drug Administration should commission an assessment to determine the effect of its regulatory process for Class II devices on facilitating or inhibiting innovation in the medical-device industry
- The Food and Drug Administration should develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices
The IOM panel also berated the FDA for foot dragging.
“After 35 years, the FDA has not completed the task of calling for PMAs for or reclassifying preamendment Class III device types,” the panel said. “Congress in 1990 directed the FDA to complete this task in a timely manner.”
While the IOM report detailed specific recommendations, the committee refrained from providing any specific recommendation on the seven questions that the FDA’s Shuren had requested. Those questions include:
- Seeking greater authority to require postmarket surveillance studies as a condition of clearance for some devices.
- Defining the scope and grounds for CDRH to exercise its authority to rescind a 510(k) clearance fully or partially.
- Clarifying when a device should no longer be available for use as a predicate.
But the panel wrote “because of time constraints, the committee was unable to study fully the seven recommendations referred to it,” in a letter to Shuren.