IOM Report Recommends FDA Scrap Its 510(k) Medical Device Review Process

July 29, 2011

A report issued today by the Institute of Medicine (IOM) recommends that the U.S. Food and Drug Administration (FDA) not try to rework its 35 year old 510(k) medical device review process, but rather scrap the process entirely and start over.

As reported here in MedTech Briefs in January, the FDA this year has been implementing twenty-five of the fifty-five changes it devised last year for its 510(k) process, but has been awaiting the report it commissioned from the IOM before implementing the more controversial changes the FDA had planned.  Today’s IOM report may completely disrupt the course in which the FDA has been heading.

The FDA commissioned the report from the IOM in September 2009, at an anticipated cost of $1.3 million.  The IOM was established in 1970 under the charter of the National Academy of Sciences, and provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a “reasonable assurance of safety and effectiveness” before a device can be marketed, and the FDA is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k) of the FFDCA.  Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market.

The FDA turned to the IOM to review the 510(k) process and answer two questions:

Does the current 510(k) process protect patients optimally and promote innovation in support of public health?

If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The IOM report has found that the current 510(k) process is flawed based on its legislative foundation. “It’s not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help,” said report committee chair David Challoner, emeritus vice president for health affairs, University of Florida, Gainesville.  “The 510(k) process cannot achieve its stated goals — to promote innovation and make safe, effective devices available to patients in a timely manner — because they are fundamentally at odds with the statutes that govern how FDA must implement the process.”  Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM also recommends that the FDA ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible. The IOM has outlined its criteria for this framework in the report.

In response to the IOM report, the FDA quickly issued a press release today stating that “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.”  The FDA is planning a public meeting in the coming weeks to discuss recommendations made by the IOM report.

IOM press release:

FDA press release:

In related news, the FDA released a draft guidance document last week to inform manufacturers, distributors, developers, FDA staff and others about how the FDA intends to apply its regulatory authorities to select software applications (i.e. “mobile apps”) designed for use on mobile platforms such as smart phones.  The FDA is soliciting public feedback on the draft document over the next 90 days.  More information is provided at

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