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2011: The Year of the 510(k)

The 510(k) process is arguably one of the most heated FDA issues right now. FDA, stakeholders, industry associations, and researchers have all stated their opinion on what they think of the process. Now the latest report in the Archives of Internal Medicine, “Medical Device Recalls and the Device Approval Process,” blasts the 510(k) process and is calling for agency reform.

The analysis stated that 71% of the 113 recalls that occurred between 2005 and 2009 involved devices that received 510(k) clearance. “These findings demonstrate systematic problems in the implementation of existing medical device regulations that have exposed patients to serious harm,” wrote Diana Zuckerman, PhD, Paul Brown, and Steve Nissen, MD. The authors state that FDA relies on 510(k)s because they’re cheaper and CDRH receives a high volume of device reviews each year. They quote the average 510(k) submission review as costing FDA $18,200 in 2005 compared with a PMA submission at $870,000 the same year. “Congress has not appropriated sufficient funds to CDRH to use the more expensive PMA process for most devices, and this large cost differential creates an incentive for CDRH to rely heavily on the 510(k) process.” They concluded that devices receiving 510(k) clearance make up more than two-thirds of the products that FDA recalls. The authors suggest several changes, including that FDA strengthen and expand its authority to conduct postmarket surveillance, and other special controls that are reserved for PMA devices, on 510(k) devices. It also wants the agency to inspect the manufacturing of 510(k) devices.

AdvaMed rebukes several of the report’s statements in a fact sheet on its Web site. According to Stephen Ubl, president and CEO of AdvaMed, the report contains “factual errors, faulty data analysis, and recommendations that would harm patient access to medical technology.” He called the paper “seriously flawed and inconsistent” with previous analysis of the same data set.

Ubl emphasized that the larger agency problem is the inconsistency and unpredictability involving device reviews. As a potential result, patients outside of the United States are receiving products (many of which were manufactured in the United States) two to three years sooner than American patients. This concern ties into America’s competitiveness in the worldwide market for medical devices and whether it’s losing its innovation edge. Ubl is hoping that improving patient access and American competitiveness is addressed through FDA’s 510(k) action plan for 2011.

In January FDA released a list of 25 items to streamline 510(k) agency processes, along with a timetable for implementing the plans. The first of its actions will happen in the spring, beginning with the establishment of a center science council. FDA separated its plan into issues related to guidances, internal and administrative matters, and programs and regulatory. Before regulatory actions are finalized, such as with draft guidances, the agency will have individual comment periods. It also will defer to the Institute of Medicine’s (IOM) report, which is scheduled to be delivered in June, for more controversial issues. The institute’s report will address whether FDA has the authority to rescind a 510(k), requiring postmarket surveillance studies as a condition of clearance, and establishing a Class IIb category. Other actions within the IOM’s report will include clarification on the use of predicate devices (and whether it should be allowed) and the potential for a statutory amendment regarding FDA’s authority on off-label use.

Some of the positive industry effects for FDA’s action plan include streamlining the de novo classification process for devices, providing more clarity regarding clinical data guidance, and addressing staffing issues such as training and available resources. FDA also plans on including updates on its planned actions throughout the year on its Web site.

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