IOM Report Recommends Scrapping 510(k) Medical Device Approval Process

The medical device industry has found itself in an uproar over a July 29, 2011 report that was issued by the Institute of Medicine (IOM) regarding the 510(k) program.  The report, which was commissioned by the FDA in 2009, included strong statements concerning the current 510(k) process.  The intent of the FDA when it commissioned the report was to have an outside entity review the 510(k) process and answer two questions:

• Does the current 510(k) clearance 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) clearance process optimally?

The FDA had already performed an internal review of the 510(k) process, initiated improvements based on industry input, and sent its conclusions to the IOM for inclusion in its review.

The IOM has made a surprisingly strong statement in recommending that the 510(k) process be scrapped, on the basis that it does not directly evaluate the safety and effectiveness of Class II medical devices.  In the opinion of the Institute, the FDA must create an entirely new framework for clearing these types of moderate-risk medical devices, as it is not possible to improve or alter the current 510(k) process in order to achieve the required safety and efficacy goals.  The IOM recommends that any new system be based on a combination of “premarket clearance and improved postmarket surveillance,” while also streamlining the administrative steps required to bring new products to market.

The medical device industry has already launched a vigorous campaign to question the conclusions of the IOM, as well as to defend the current FDA strategy of making targeted changes to the 510(k) process in order to preserve what is currently working well while simultaneously introducing new efficiencies.  It is planned that these changes will help make it easier for the American medical device industry to stay competitive on the global marketplace without sacrificing public safety.

Naturally, the thought of a more restrictive medical device clearance process is of great concern for medical device manufacturers already struggling with the current set of FDA regulations, which have been regularly criticized for their lack of transparency and predictability.  An open comment period on the IOM report has been initiated by the FDA, and this will no doubt be taken advantage of by industry groups like AdvaMed, DuVal & Associates, and several members of Congress and the Senate who have already spoken up against the IOM’s recommendations.

While the Institute of Medicine delivered its report at the behest of the FDA, Jeffrey Shuren, the chief of the Center for Devices and Radiological Health (CDRH), has made several statements which could be seen as attempts to calm the storm that has been kicked up by the IOM findings.  Specifically, Shuren has referenced his belief that the 510(k) process should be improved rather than eliminated completely, and that additional funding could go a long way towards creating a truly comprehensive and robust device review program.  Shuren was also careful to state that the FDA did not believe that current 510(k) practices were endangering the lives of Americans.

MDCI will continue to monitor the industry and regulatory reaction to the IOM report, and keep readers informed of any important policy shifts or opinions related to the still-developing story.

Benjamin Hunting
MDCI Blogging Team