Industry Supports 510(k) Review Process

Medical device companies—as if they didn’t have enough on their plates at the moment—are eager to learn how the most common U.S. Food and Drug Administration (FDA) review process is going to change in the near and long term.

The agency’s 510(k) device evaluation process has been under the microscope recently—under attack from some lawmakers and industry watchdog groups for not being robust enough, particularly when it comes to more advanced devices. The head of the FDA’s Center for Devices and Radiological Health (CDRH) recently stepped down, in part because of fallout from 510(k) program. To add fuel to critics’ fire, the agency recently admitted it “failed” when it cleared the Menaflex collagen scaffold by ReGen.

According to FDA Deputy Commissioner Joshua Sharfstein, there were “definite problems in the review process” of Menaflex. In December 2008, the FDA cleared Menaflex to be marketed for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus in the knee.

In response, the FDA recently asked the Institute of Medicine (IOM) to conduct a two-year study of the program and to provide recommendations for changes, if necessary. In addition, officials within CDRH have said they will implement an internal review process immediately. As part of its study, the IOM will convene a committee to answer two principal questions: Does the current 510(k) process optimally protect patients 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? The IOM review is supposed to be completed in 2011.

Despite all the wrangling, the message from some industry insiders, however, seems to be: What’s the big deal?

“[The 510(k) process] works well,” said Steve Ubl, president and CEO, of the Advanced Medical Technology Association (AdvaMed) recently told reporters during a press briefing during the association’s annual conference in Washington, D.C. “I think some of the reporting has been misleading. It is a good, science-based process. That said, any process can benefit from more clarity.”

At the AdvaMed medtech conference, a panel of industry experts outlined what some of the misconceptions of the program have been, and how, perhaps, the problems may have been blown a little out of proportion.

The FDA classifies medical devices into three categories depending upon the product’s level of risk. Class III devices, which have the highest level of risk, generally require premarket approval application (PMA) to prove safety and efficacy before they are marketed. Class I and Class II devices usually are lower risk. Most Class II devices are cleared through the 510(k) process.

The agency requires that a 510(k) device is at least as safe and effective—what the FDA calls “substantially equivalent”—to a product currently on the market that is not subject to a PMA. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and, thus, may require premarket approval.

The 510(k) process was established under the Medical Device Amendments of 1976 with two goals: to make safe and effective devices available to consumers, and to promote innovation in the medical device industry. It is the largest premarket device program at the agency, and 50 percent of all devices make it to market via the 510(k) route. The agency receives anywhere from 3,000-4,000 submissions per year, compared to 30-50 original PMAs, according to officials.

“This is not a rubber stamp or ‘fast-track’ approval as some mainstream news outlets have incorrectly identified it,” said Heather Rosecrans, director of 510(k) staff at the FDA’s Center for Devices and Radiological Health (CDRH). She said that most significant-risk devices—such as hip implants, dialysis machines or infusion pumps, for example—go through the 510(k) process, because significant market predicate devices exist.

“This is a risk-based, data-driven evaluation,” she added, noting that some 510(k) applications require clinical trial data—roughly 10 percent of submissions, in fact. Critics have charged that the agency has used the 510(k) process to clear riskier devices that should most likely undergo a PMA.

The Government Accountability Office (GAO) examined the process and released a study in January this year. The study revealed that some Class III products—”pre-amendments” devices, meaning they were on the market before 1976—are allowed to go through the 510(k) process until FDA issues a rule explicitly requiring a PMA. However, more than 14 years after publishing plans to do so, as required by a 1990 statute, FDA has failed to either reassign the device types to the medium-risk Class II category, or keep them Class III and require PMA approval. Study authors hasted to add, however, that about 1 percent of the approximately 5,000 submissions for Class II or III devices in the three-year study period (2005-2007) had a new intended use, and about 15 percent had new technological characteristics.
In response to the calls for reform, Rosecrans and other FDA officials said technology and the medical device industry have changed dramatically during the past three decades, making it an appropriate time for a review of the adequacy of the premarket notification program.

“The GAO report was favorable, overall,” said Patricia Shrader, vice president of corporate regulatory, public policy and communications for BD. “I think that fact gets lost. Media reports have been sensational, misleading inaccurate, anecdotal and random. The report didn’t have such a bad outcome except that there were a handful of pre-amendment devices being reviewed under 510(k). Big deal. So what?”

Many insiders consider some sort of review of the program on Capitol Hill is likely, but for now falls far down on lawmakers’ priority list.