FDA Report Outlines Plan for Improvements in Device Review

The U.S. Food and Drug Administration (FDA) released a report on Nov. 28 detailing how its Center for Devices and Radiological Health (CDRH) plans to improve and accelerate medical device reviews. Earlier this year, U.S. lawmakers approved the reauthorization of the Medical Device User Fee Act (MDUFA III). The renewed program allows the FDA to collect more fees from the drug and medical device sectors in exchange for meeting certain performance goals related to timely consideration of their product marketing applications. Heavily criticized for unpredictability and what was seen as unreasonably long review times, the FDA is now obligated to speed up review processes and deliver timely premarket approvals and 510(k) clearances.

In January of last year, the FDA introduced a plan of action to “modernize and improve” the agency’s premarket review of medical devices. According to regulators, in the two years hence, FDA’s speed and predictability have improved for the first time in the past decade. It has also been clearing more devices for sale than in the past—about 80 percent of devices submitted for 510(k) clearance were approved for sale in 2012, a 75 percent improvement over 2010. Better prepared applications have been the key to these improved numbers, reported the FDA.

Besides generally streamlining processes by hiring more personnel, the FDA also plans to promote greater transparency, interaction, and collaboration between the agency and industry during premarket reviews. There will be “early, informative meetings and interactions between CDRH staff and device manufacturers about what data should be in an application,” which is hoped to increase predictability of the review process. FDA also aims to improve the CDRH’s understanding of new technologies by increasing the network of experts the from outside the agency who can be “called on to help answer scientific questions quickly.” Of particular interest to the FDA recently are issues of cyber security, and the security of wireless devices.

The CDRH is also embarking on what it has dubbed the “Innovation Initiative,” a program intended to maintain the United States’ position as the global leader in medical device innovation. A typical criticism levied against the FDA has been that its unpredictability and perceived lack of efficiency has driven a lot of technology to Europe, where companies can pass devices through trial phases and achieve regulatory approval much more rapidly. The agency aims to change this perception as well.

The CDRH will, according to the report, also create incentives for conducting clinical trials in the United States, including a appointing entrepreneurs-in-residence (the EIR program) to bring “state-of-the-art thinking in business processes, device innovation, decision science, and information technology to device reviews.” The EIR program was initially intended to last only six months, but was so successful the CDRH is continuing it. In its first round, the CDRH hired 20 outside entrepreneurs and device innovators from venues including industry, universities, and the venture capital sector.

Since the passage of MDUFA III, FDA has informed industry in a series of reports how it plans to implement its new obligations. However, 64 percent of respondents to a recent survey of device makers said they are still dissatisfied with the 510(k) clearance process for devices. The survey was commissioned by MedTech Resource Alliance based in Minnetonka, Minn., and surveyed 128 participants. Among cited sources of discontent were lack of communication and a lack of scientific expertise at the agency—nonetheless, with its new report, the FDA seems to be addressing the latter issue head-on.

Despite the FDA’s best efforts, however, negative chatter has hindered the agency’s hiring of new top talent. A report released by the nonprofit organization Partnership for Public Service concluded that “while the political dynamic will always be part of the process and difficult for the FDA to control, its impact can hurt morale and create an image that may discourage prospective employees.”

The Partnership found that scientists do not perceive FDA as a place where they can innovate, compared to academia, industry or at the National Institute of Health, for example. “One biologist said it took her seven years to get over the ‘FDA stigma’ and actually make the leap to come to work at the agency,” the report stated. “Even though the work at the FDA was more in line with her field and what she wanted to pursue, she refused job offers after hearing negative comments about the FDA and having the feeling that the FDA was not the place for top scientists. This sentiment was echoed by many reviewers and scientists who work at the FDA.”