FDA Recommends Changes to 510(k) Process

Reed Miller

August 06, 2010

August 6, 2010 (Silver Spring, Maryland) — As the Institute of Medicine continues its review of the FDA's 510(k) clearance process for devices that do not require full premarket approval (PMA) review, the agency itself has released two preliminary documents with a series of recommendations on how to improve the 510(k) system [1,2].

The agency is soliciting public input on its recommendations. Once it has finished assessment of the public input and "other necessary reviews," it will announce which improvements it plans to implement, with timelines for implementation, while referring some ideas to the Institute of Medicine for further review.

The 510(k), or premarket notification, process is the regulatory path whereby the FDA clears a device for marketing in the US if a company can prove its device is "substantially equivalent" to one already on the market. The FDA allows devices to take this path, instead of requiring the company to go through the complete PMA process, for devices that are considered less dangerous and/or are part of a well-understood class of devices. The 510(k) process is usually faster and less costly for the sponsor than the PMA process, which requires the sponsor to show the device is safe and effective. The PMA process generally requires at least one major clinical trial, while a sponsor can often prove substantial equivalence for a 510(k) with relatively little new clinical data.

In recent years, some agency staff and outside observers have questioned whether the 510(k) system is allowing devices to enter the market without sufficient assurance of safety or effectiveness. And some observers, including critics in Congress, maintain that the rules for 510(k)s have loopholes that allow companies to market new technology in the guise of previously approved devices. On the other side, manufacturers and their lawyers have complained that the agency's handling of 510(k) applications is unpredictable, inconsistent, and not transparent, thereby hindering device development and preventing innovative technologies from reaching the market.

Beginning this spring, a committee convened by the Institute of Medicine has been reviewing the 510(k) premarket notification process to examine whether the current process "optimally protects patients and promotes innovation in support of public health" and what regulatory or administrative changes are needed to optimally achieve the goals of the 510(k) process. So far, the IOM has held three public meetings to solicit input for its report, which it expects to complete in mid-2011.

The first set of the FDA's preliminary recommendations, announced August 4, focuses on ways to "strengthen and clarify" the 510(k) process. The second set of the FDA's preliminary recommendations, released the same day, evaluates how the Center for Devices and Radiological Health (CDRH) uses science to make decisions "with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation," the agency explains in a release announcing both documents.

The first set of recommendations was created by the 510(k) working group of representatives from across the FDA CDRH, which gathered input from CDRH employees and managers and a range of external constituencies. Among the highlights of the first document is the FDA's acknowledgement that pivotal terms in the definition of "substantial equivalence" are unclear and that the agency should clarify those terms in guidance for industry and new training for its reviewers and managers.

The working group found that "substantial equivalence to a predicate" is generally a reasonable standard to ensure that the device is safe and effective, but that "current FDA regulations and practice may allow for some types of predicate comparisons that are insufficient to consistently provide such assurance." For example, some 510(k)s are predicated on devices that have already been withdrawn from the market due to issues of safety or effectiveness.

Also, some 510(k)s have been cleared based on equivalence to so-called "split predicates," whereby the new device is compared with one older device with respect to its intended use and another with respect to its technological characteristics. "The use of a 'split predicate' is akin to combining different attributes of more than one device into a single, nonexistent predicate device whose risks and benefits are unknown," the working group concludes.

It recommends that the FDA work with stakeholders to create new rules for when a device can or cannot be used as a predicate and that CDRH consider explicitly disallowing "split predicates."

The second document, written by the CDRH's task force on the utilization of science in regulatory decision making, recommends that the CDRH improve the ability of its staff to access high-quality information about regulated products because, currently, "challenges related to CDRH's current data sources, methods, and administrative practices make it difficult for the center to efficiently and effectively obtain complete information about the risks and benefits of regulated products across the total product life cycle."

The document also stresses the need for the CDRH to address its "staffing needs" and to "enhance processes and systems that support centerwide integration" while also taking advantage of external scientific expertise.

In addition to improving its internal coordination and communication, the CDRH must improve the communication of its current thinking and expectations to outside stakeholders and remedy the current lack of transparency about the rationale for some of its decisions, the task force concludes.

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