Next year FDA will look to renew for a third time the Medical Device User Fee and Modernization Act (MDUFMA). As such, it seems a good time to look at the program and discuss the merits and limitations that MDUFMA has brought to the medical device regulatory scheme.
 

MDUFMA’s goals were twofold: to improve review times and to provide support for cash- and otherwise resource-strapped FDA.
 

Has the program been a success? John J. Smith MD, JD, a partner in the medical device group at Hogan Lovells LLP, says the answer is a clear “yes and no.”
 

MDUFMA resulted in an improvement of FDA’s self-reported time to final decisions. The debate is whether those decisions are better ones. In the past, for complex submissions, there was often the opportunity for multiple rounds of review” says Smith. “Now, the agency seems unwilling to issue more than two requests for additional information before reaching a final decision. If FDA can’t get the answers it wants in a second request for information, there’s a good chance that the agency will issue a not substantially equivalent (NSE) letter.”
 

Such responses undoubtedly help FDA meet its MDUFMA goals, but expedience comes at price. An NSE finding leads to the need to refile the 510(k) and new multiple rounds of review, delaying the availability of the new technology to patients and physicians. Most of these devices are ultimately cleared but only after significant bureaucratic delays.
 

An internal report from FDA released in April found that the percentage of 510(k) applications that resulted in NSEs doubled from 4% in FY 2009 to 8% in FY 2010. It’s a troubling statistic that reflects the agency’s need to meet user fee review goals and its increasing requests for data in 510(k) notices, says Smith.
 

As a consequence, devices that have taken years to develop and test suffer. “An NSE decision issued because of a need for more information will likely be cleared once that data is submitted in a later 510(k). Thus, devices that have clear clinical value could be available overseas but be delayed in the United States,” Smith says.
 

AdvaMed predicts that PMA and 510(k) submissions will take longer with MDUFMA III, since FDA is mulling new review deadlines. “We’re very concerned that [FDA] is not meeting its performance targets around PMA products,” AdvaMed President Stephen Ubl said at a press briefing in March. “And while it’s making some of the goals on the 510(k) side, the story behind the story is a lot of the review cycles are being delayed substantially.”
 

More troubling, however, are the unintended consequences of MDUFMA, says Smith. For example, firms looking for investigational device exemption (IDE) for certain devices used to enjoy considerable help from FDA reviewers presubmission. But PreIDEs are not subject to user fee timelines and seem to have dropped down FDA’s priority list. The average time for preIDEs is about 150 days, greatly reducing the benefits of the process to company’s seeking to start their studies on a timely basis.
 

What industry needs from FDA is simple, says Smith: predictability and transparency. “Industry wants these principles built into the review process. FDA must limit unintended consequences and ensure that every submission is given the resources necessary to perform a reasonable and timely review.”
 

The old saying in design and manufacturing is that everyone wants fast, good, and cheap, and out of those three, you can only expect two. It may be that medical device makers will have to further compromise by giving up both cheap and fast from FDA, just to get “good.”