Institute of Medicine Report Calls for Replacement of 510(k) Process, FDA to Hold Meeting for Public Comments

July 29, 2011—According to a report by the Institute of Medicine of the National Academies of Science, the US Food and Drug Administration (FDA) should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. The report was drafted by Chairman David R. Challoner, MD, et al of the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process of the Institute of Medicine's Board on Population Health and Public Health Practice.

The report, which was commissioned by the FDA, concluded that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk class II devices and cannot be transformed into one.

On July 29, the FDA announced that it will open a public docket to begin receiving comments regarding the Institute of Medicine's report. The FDA is planning to hold a public meeting in the coming weeks to discuss the recommendations made in the report. The FDA advised that none of the Institute of Medicine's recommendations are binding and that some, such as the recommendation to design a new regulatory framework for moderate-risk class II devices, may require congressional actions. However, the FDA plans to continue its review of the report and to solicit input from stakeholders regarding the recommendations that involve existing FDA authorities, the agency stated.

“The FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” commented Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health.

According to the Institute of Medicine, the report recommended that the FDA's finite resources would be better invested in developing a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of class II devices throughout the duration of their use. The FDA should also ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible.

The report asserted that the current 510(k) clearance process, which relies on substantial equivalence as an expedient way to evaluate moderate-risk class II devices, cannot ensure that devices reaching the market are safe and effective. The majority of the devices that are used as the basis for comparison were never reviewed for safety or effectiveness. The report noted that this does not mean that they or the devices that followed them are unsafe; the continual use of many of these products in clinical practice provides a level of confidence in their safety and effectiveness. However, 510(k) clearance does not determine a device to be safe or effective.

The Institute of Medicine committee was neither charged with nor able to detail what the new framework should entail, but it addressed key attributes of an improved process, including that it be clear, fair, and predictable and make use of regulatory tools and authority to ensure safety and effectiveness throughout the duration of a product's use. The report states that the FDA should explore whether a modified version of its de novo process could replace the 510(k) process. The de novo process reduces the amount of information that manufacturers must supply for devices that are deemed to be of low or moderate risk but that have no predicate devices against which to be compared. Changes would be necessary to fix problems that make the de novo process time-consuming and difficult to navigate before the FDA initiates a pilot program.

The report observed that no premarket regulatory system can guarantee that all medical devices will be completely safe and effective when they reach the market, that it would be impractical for all devices to undergo the same sort of premarket testing that drugs must go through, and that even the more rigorous process for drug approval cannot ensure that every safety problem is caught. Given that both patients and the industry desire a streamlined process to get new devices to market in a timely fashion, it is essential to have a robust postmarket surveillance of these products. However, the committee found substantial weaknesses in current postmarket oversight of devices and heard from the FDA that it faces limitations on its authority to address problems with products on the market.

According to the Institute of Medicine, the report provided the following recommendations:

According to the FDA, the agency has already taken several steps to improve the process that includes issuing a draft guidance clarifying when manufacturer changes to a 510(k)-cleared device already on the market warrants a new 510(k) submission. It has also taken several steps under its 515 Program Initiative to address all outstanding preamendment class III device types subject to 510(k) review. The Center for Devices and Radiological Health Web site includes up-to-date information on the status of each of the 25 remaining device types, and the agency plans to complete this process by the end of 2012.

The FDA plans to provide draft guidance to strengthen and streamline the de novo classification path to market for novel low- and moderate-risk devices that are not substantially equivalent to an existing device. It will draft the 510(k) Paradigm guidance, which will clarify certain aspects of the FDA's 510(k) substantial equivalence review. Additionally, it will issue a proposed rule on unique device identifiers this fall. The Institute of Medicine noted that these identifiers would be a meaningful change to the agency's postmarket capability.

Dr. Shuren of the FDA stated, “We appreciate the Institute of Medicine's report on the 510(k) program and agree that the public should continue to feel confident in the medical devices on the market today. Medical devices in the United States have a strong track record of safety and effectiveness. The 510(k) program has helped support a robust medical device industry in the United States and has helped bring lower-risk devices to market for the patients who need them.” He concluded, “Many of the Institute of Medicine findings parallel changes already underway at the FDA to improve how we regulate devices. These actions, plus a sufficiently funded device review program, will contribute to a stronger program. Any major modifications made to the agency's premarket review programs should be based on sound science and through thoughtful and transparent discussion.”

The FDA commissioned the Institute of Medicine report titled “Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years” in September 2009 in response to concerns raised by various stakeholders. The FDA undertook an assessment of its 510(k) program to determine which, if any, changes should be made to improve the program and update it so that it adequately addresses the level of current device complexity and today's marketplace. To that end, the FDA stated that it has committed to an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework for not only to the 510(k) process but also its device review programs in general.