IOM to FDA: Scrap 510(k), start fresh
 |
Despite a growing number of FDA efforts at reforming the 510(k) process in past months, the committee claimed continuing to invest in it is not “a wise use of the FDA’s resources,” but refused to make specific reform recommendations, instead encouraging the administration to scrap the process altogether and start fresh.
“[The committee] believes that the FDA’s resources would be put to better use in obtaining information needed to develop a new regulatory framework for Class II medical devices and addressing problems with other components of the medical-device regulatory framework,” IOM stated.
Among some of the committee’s findings, in "Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years," the authors noted a “fundamental flaw” relating to “substantial equivalents.” The current device approval process allows certain products to be cleared if a device on the market can be demonstrated as substantially equivalent. As more medical devices move through the 510(k) process providing a substantial equivalent, more uncertainty builds about the safety and effectiveness of products, the authors noted—particularly if the substantial equivalent hit the market prior to the enactment of the 510(k) process in 1976.
Importantly, the authors noted no reason for concern about the safety of products currently on the market.
In a press conference held in Washington D.C., after the release of the report, lead author David R. Challoner, MD, vice president for health affairs, emeritus, University of Florida, Gainesville, Fla., said the committee worked to answer two questions: Does the current 510(k) process protect patients optimally and promote innovation in support of public health? If not, what legislative, regulatory or administrative changes are recommended to achieve the goals of the 510(k) process optimally?
The committee concluded that it is “indeterminable” whether the 510(k) process has had a positive or negative effect on innovation, and in order to answer that question, the FDA should commission an assessment. They also found that the process needs to be scrapped, and recommended developing a new integrated premarket and postmarket framework that provides reasonable assurance of safety and effectiveness.
According to the committee, a new regulatory framework should:
- Be based on sound science.
- Be clear, predictable, straightforward and fair.
- Be self-sustaining and self-improving.
- Facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle.
- Use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness.
- Be risk-based.
When asked about an interim plan, should the process be eliminated, committee member William W. Vodra, JD, former senior counsel at Arnold & Porter, noted that the intent of the committee was not to come up with a new process, because “it was well beyond our mandate.” He recommended evaluating the entire medical device approval process, not just the 510(k), in order to establish new regulation. “We don’t believe in shutting down the system tonight. It’s working adequately in the short term; it’s just asking the wrong question."
The FDA quickly responded to the release of the IOM report, stating that it does not believe the process should be eliminated; however, it is open to ideas. The agency said it will open a docket to begin receiving public comments on the IOM report, and will hold a public meeting in coming weeks to discuss the recommendations.
“We appreciate the IOM’s report on the 510(k) program, and agree that the public should continue to feel confident in the medical devices on the market today,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “Medical devices in the U.S. have a strong record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the U.S. and has helped bring lower-risk devices to market for patients who need them.”
The FDA also noted its recent actions to improve predictability, consistency and transparency. “Many of the IOM findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program,” said Shuren. “Any major modifications made to the agency’s premarket review programs should be based on sound science and through thoughtful and transparent discussion.”
The Medical Imaging Technology Association (MITA) stated the recommendations offered in the 246-page IOM document come too late in the 510(k) reform process, and presented the wrong approach.
“The 510(k) reform effort has been underway for well over a year and the IOM’s recommendations come very late in the process, falling far outside the current conversation,” said Dave Fisher, executive director of MITA. “Manufacturers have been working with the FDA and the broader imaging community to identify and implement targeted and effective improvements to the 510(k) review process. It is imperative that this effort continue.”
Responding to the FDA’s release on the report, Challoner commended its intent to begin a public discussion. “That’s what we wished would happen,” he said. “The 510(k) process needs to be modified in the interim, but there is something fundamentally flawed, which will take time and discussion from all participants in the arena."
The report was the result of 16 months of evaluation of the FDA’s 510(k) medical device clearance process, completed by an IOM committee of 12 members in the field at the request of the FDA. The 510(k) process has been the subject of criticism, based on reported problems and delays from numerous organizations, including the Government Accountability Office, the Department of Health and Human Services, courts, the public, industry and legislators.
An IOM report brief can be found here.