FDA’s 510(k) Review Process Enters New Period of Debate

The U.S. Food and Drug Administration (FDA) is getting an earful from all sides as the debate about changes to the 510(k) clearance process moves forward. In August, the agency released two preliminary reports based on internal studies that recommended next steps to revamp the mechanism by which most medical devices reach physicians and consumers.

According to the FDA’s Center for Devices and Radiological Health (CDRH), the reports released for public comment represented “concrete steps” regulators could take to “advance three key objectives of a balanced public health approach.” The objectives the reports noted were: fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.

“Together, they represent a blueprint for smarter medical device oversight, with the tools CDRH needs to drive innovation and help bring the best technologies to patients,” wrote CDRH Director Jeffrey Shuren, M.D., following the release of the center’s findings. “CDRH’s responsibility is two-fold: to protect and promote the public health. We use our oversight to keep patients from harm, and we foster the development of safe and effective new products. The recommendations in today’s reports represent significant opportunities to increase our effectiveness in carrying out both parts of our mission. By increasing the predictability, reliability and efficiency of our regulatory pathways, we can help provide better treatments and diagnostics to patients more quickly, stimulate investment in and development of promising new technologies to meet critical public health needs, and increase the global market position of U.S. medical devices.”

CDRH made more than 60 recommendations for altering the process, include limiting the use of predicate-device comparisons in new-product applications; streamlining the de-novo review process for low-risk devices that have no predicate comparisons; and asking lawmakers to give the FDA greater authority to remove a medical device from the market. As the clearance process stands now, a device going the 510(k) route requires comparison to a device already on the market. The devices that proceed in this manner usually do not require clinical data (roughly 10-15 percent do), and they are products that don’t carry as much risk for the patient. This makes the overall process much quicker and less expensive. The 510(k) program has been criticized in recent years as not being thorough enough and perhaps letting riskier devices slip through what some have categorized as a “less-intensive” review process. For example, the non-profit advocacy group Public Citizen has described the process as failing “to keep dangerous and ineffective medical devices from the market.”

The Advanced Medical Technology Association (AdvaMed)—the device industry’s largest trade group—on the last day comments were due in October, provided its two cents. AdvaMed has lobbied against a major overhaul, saying the process works well already and needs only modest updating. The association highlighted a report, conducted by an outside group with AdvaMed’s financial backing, that seemed to indicate only a small number of devices approved through the 510(k) process since 1998 were involved in serious recalls.

AdvaMed recommends, among other steps, more training for FDA reviewers, but not other moves such as beefed up FDA authority to rescind device approvals. Among the FDA’s proposals, AdvaMed argued against creating a subset of Class II devices (products with moderate risk to patients) that would require clinical or manufacturing data. AdvaMed supports identifying a “small, focused subset” of such devices, but is concerned the agency is targeting a much broader range of products. Public Citizen, however, backs dividing Class II devices and said the FDA should require clinical data for all devices in a new Class IIb category. The FDA said drug-infusion pumps, which have had a sketchy performance and manufacturing history, are one example of a device group that could fall into this new category.

“Wholesale changes to a program that has such a strong record of protecting American patients while facilitating innovation and timely patient access to improved medical devices and diagnostics are not needed,” AdvaMed President and CEO Stephen Ubl said in a news release.

In addition, AdvaMed officials claim that the FDA’s proposals to resolve confusion about certain key 510(k) terms could instead add confusion and delay product clearances. It also questioned the FDA’s proposal to increase its authority to consider “off-label” device uses in clearance decisions. Implementing so many changes likely would “overwhelm” the agency as well as the industry, according to AdvaMed, and would be “disruptive.”

The FDA has said it could make some 510(k) changes this year, after taking public comments into account. Further 510(k) changes could come next year after a multimillion-dollar, FDA-requested review by the nonprofit Institute of Medicine wraps up.

So, in short, there’s more to come.