IOM Recommends Replacing the FDA 510(k) Clearance Process

On July 29, 2011, the Institute of Medicine (IOM) released its long-awaited report, "Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years." In 2009, the Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to evaluate the FDA's 510(K) clearance process and provide recommendations to improve the current process (learn more).
           Visit the National Academies Press website to read the FDA 510(k) Clearance Process report online »

In February 2010, the Society attended and participated in the first public meeting hosted by the internal FDA working group tasked to reevaluate and potentially modifying the 510(k) program.Society attended and participated in the first public meeting hosted by the internal FDA working group tasked to reevaluate and potentially modifying the 510(k) program.

What is the FDA 510(k) Process?
The 510(K) clearance process, also known as pre-market notifications, was established to permit new medical devices to be brought to the market by demonstrating only that they were substantially equivalent to already currently marketed devices, referred to as predicate.

Only Class II devices (also known as moderate risk devices) can be cleared by the FDA through the 510(k) process. Class III devices (such as pacemakers and ICDs) are required to go through the pre-market approval (PMA) process, even if there is an existing device on the market. 

IOM's Recommendations
The IOM convened a committee of 12 experts to evaluate the pre-market notifications. While evaluating the 510(k) clearance process, the IOM focused on two questions:

1. Does the current 510(k) clearance process optimally protect patients and promote innovation in support of public health?
2. If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) clearance process?

The IOM concluded that the 510(k) process was not intended to determine whether a new device provides a reasonable assurance of safety and effectiveness or whether it promotes innovation. Rather, according to the IOM, it was intended only to determine whether the new device is substantially equivalent to an already marketed (predicate) device, and there was therefore an inherent conflict between the legislative framework of the 510(k) program and the FDA's stated policy goals.

The IOM recommends replacing the 510(k) clearance process as soon as possible with "an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle."

Although the report did not describe a specific regulatory framework, the IOM committee outlined what it considers to be an "ideal regulatory framework:" 

The process should:

• be based on sound science
• be clear, predictable, straightforward, and fair
• be self-sustaining and self-improving
• facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle
• apply relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness
• be risk-based

FDA's Internal Review of the 510(k) Process
In parallel to the IOM's evaluation, the FDA convened its own internal review workgroup. After initially seeking stakeholders' input during several public meetings, the internal FDA Task Force released 55 recommendations on January 19, 2011 to improve the 510(k) process. Stakeholders were invited to comment on the recommendations during a public comment period. In response to the feedback received from stakeholders, the FDA made changes to the proposed recommendations.

The 25 proposed changes released January 19 include:

• A new effort to streamline the review process for innovative products with a lower risk to patient safety through a process called the "de novo" process
• New guidance for industry to clarify when clinical data should be submitted to increase the predictability of new devices and transparency within the FDA approval process
• The creation of a new group of experts who can use their knowledge and experience to help the FDA address emerging scientific concerns and facts regarding new medical device technologies
• The establishment of a new Center Science Council of senior FDA experts within the agency's medical device center to oversee the agency's science-based decision making
• A commitment to continue and strengthen the monitoring of devices after they are introduced to the market. A public database will summarize and explain all FDA decisions regarding the approval of devices.

For more information on the changes proposed by the FDA, view the complete list of rules.

Next Steps
The FDA announced on Friday, July 29 that it will hold a public meeting on the report soon and opened a public docket requesting public comments on the IOM report.