Regulatory Update: October 2010

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA’s review process for medical devices still needs clarification, and the link between user fees and performance needs strengthening, representatives of medical device manufacturers testified at a public hearing.

The FDA held the public hearing in September before beginning its update of the Medical Device User Fee and Modernization Act (MDUFMA), which is up for renewal in 2012. The law imposes user fees on medical-device companies in order to provide the FDA with sufficient resources to review the safety of medical devices and approve them in a timely manner. The act was first passed in 2002, and it was renewed for a five-year period in 2007.

Dave Fisher, executive director of the Medical Imaging & Technology Alliance, says, “The general perception, among our members, is that the link between user fees and FDA performance is broken.” Medical-device companies provided nearly $300 million in user fees between 2008 and 2010 to help fund the program.

Review times for the 510(k) evaluation process have lengthened during the past several years, according to the Office of Device Evaluation’s 2009 Annual Performance Report. In 2005, the average total elapsed time from receipt to final decision was 87 days. By 2007, that figure had risen to a high of 117 days; it dropped to 98 days in 2009. Mark Leahey, president and CEO of the Medical Device Manufacturers Association, testified at the public hearing. He says, “I think 2005 was kind of the high-water mark, as far as performance goes, and since then, it has deteriorated a bit, in some areas.”

Leahey also points to a 2006 FDA-commissioned report that found that almost 76% of responding device manufacturers perceived that MDUFMA goals have not resulted in meaningful improvements in either the predictability or the timeliness of medical-device review.

Although many of these issues predate the current FDA leadership, Leahey adds, “If we pose the same question right now—based on the feedback we receive from members—that 70% number, I think, will be a bit higher.” More and more anecdotal examples demonstrate where interactive collaboration and coordination among manufacturers and FDA reviewers might be falling short, hindering the review process, Leahey says.

Fisher points out one new process that needs clarification: The FDA issued guidance, last year, that was intended to clarify the review process for the use of contrast agents with imaging equipment; however, the end result appears to have made the process more complicated. “The technology has stopped in its tracks,” Fisher says. “Companies are taking some features out of their products to eliminate any chance that contrast agents might be used with their products.” This leaves physicians to rely on older equipment that allows the use of contrast agents or to purchase new products that don’t include innovations involving contrast agents, Fisher says.

The FDA notes that it has met many of the goals outlined during the last renewal of the act and that its workload has increased over the years, putting a strain on the agency’s resources. In addition, the FDA recently issued two comprehensive evaluations that look at, and make recommendations about, the agency’s 510(k) review process and the use of science in the decision-making process.

Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, says, “Taken together, these preliminary reports show a smarter FDA—an agency that recognizes both sides of our mission to protect and promote public health. The agency is ready to make necessary improvements to support device innovation while ensuring patients receive safe and effective devices.”

In-office Ancillary-service Exception

The Medicare Payment Advisory Commission (MedPAC) began discussions at its September meeting on whether to turn any of the growth-reducing strategies that it has researched for imaging services into a formal recommendation for a future report. These strategies were outlined in MedPAC’s June report, Aligning Incentives in Medicare, as part of the commission’s review of the in-office ancillary-service exception outlined in the Stark self-referral law. In addition to imaging services, this exception applies to in-office therapy services and laboratory tests.

Some of the suggested growth-reducing strategies include requiring certain physicians to get preauthorization for procedures, reducing payment rates for self-referring physicians, and limiting