IOM Says FDA Should Overhaul 510(k) Medical Device Approval Process
FDA should dismantle the 510(k) program for expediently approving medical devices because it does not guarantee their safety or efficacy, according to a review by an Institute of Medicine panel, the AP/Washington Post reports.
The 12-member IOM review panel was commissioned by FDA to examine the 510(k) device approval process. Devices are eligible for the 510(k) system if FDA deems them similar to devices already on the market (AP/Washington Post, 7/29).
Details of Review
The panel said that the 510(k) process does not protect patients or promote innovation. It said that some medical devices considered by FDA to be "predicate devices" have been on the market since before certain medical device amendments, meaning new devices are being approved because of their similarity to older ones that never were found to be safe and effective.
According to IOM, the 510(k) process also does not include enough assessment of devices after they are put on the market. The panel said it found "substantial problems" in how devices are examined after their approved by FDA.
The panel said that FDA should develop a new regulatory framework instead of dedicating its resources to fixing the current process.
The panel concluded that "the 510(k) process generally is not intended to evaluate the safety and effectiveness of medical devices and, furthermore, cannot be transformed into a premarket evaluation of safety and effectiveness."
It added that "FDA's finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."
IOM said any new regulatory framework should:
- Be based upon provable research;
- Be straightforward, clear and predictable;
- Be fair;
- Be risk-based; and
- Facilitate expedient innovation that improves public health (Walker, MedPage Today, 7/29).
FDA Rebukes Findings
FDA dismissed the findings and said it will continue to modify the 510(k) process, which it has been working for more than a year to improve, the AP/Post reports.
Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said, "FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches" (AP/Washington Post, 7/29).
He added, "Many of the IOM findings parallel changes already under way at FDA to improve how we regulate devices. These actions, plus a sufficiently funded device-review program, will contribute to a stronger program."
The device industry trade group Advanced Medical Technology Association also rejected the report.
AdvaMed CEO Stephen Ubl said, "The comprehensive action plan FDA has already announced, if properly executed, could address many of these issues" (McCarthy, National Journal, 7/29).
In addition, various lawmakers opposed IOM's recommendations.
Sen. Kay Hagan (D-N.C.) said that she does not support eliminating the 510(k) process, while some Republicans -- such as Sen. Orrin Hatch (R-Utah) -- suggested that the recommendations only would create more uncertainty for the medical device industry after the federal health reform law implemented a medical device tax.
IOM "appeared sanguine" in reaction to the opposition, according to National Journal. Panel member William Vodra, former senior counsel at Arnold and Porter, said, "We do not believe that you have to shut down the system tonight," adding, "But in 2046, we don't think this country will be OK with waiving safety because a device showed equivalence to another item" (McCarthy, National Journal, 8/1).