Medical Device & Diagnostic Industry Magazine
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Originally Published MDDI January 2006

From the Editors

Shortening decision and cycle times has caused FDA to lose sight of other aspects of the regulatory process. This must be fixed when MDUFMA is reauthorized.

Erik Swain for the Editors

Thanks to the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), FDA has been reviewing premarket approval (PMA) and 510(k) submissions faster. But in its efforts to meet those goals, other parts of the regulatory process have been deemphasized, maybe even neglected. When MDUFMA is reauthorized in 2007, those issues will have to be addressed.

Signs of FDA's own frustration at the overemphasis on MDUFMA goals began to show publicly at the Regulatory Affairs Professionals Society (RAPS) annual conference in October.

“We have made progress, but at a price,” Thinh X. Nguyen, director of CDRH's Premarket Approval Section, told those who attended a session on MDUFMA. “The staff is working at the limits of their abilities. ‘Luxuries' such as training, standards work, and guidance development have been neglected. We can't continue to improve performance without additional resources. If funding is flat, we will continue to meet [MDUFMA] goals, but will be unable to expand other programs.”

At the MDUFMA Stakeholders Meeting on November 17, 2005, in Gaithersburg, MD, industry painted a similar picture of other tasks falling by the wayside because the Office of Device Evaluation (ODE) was under so much pressure to meet MDUFMA goals. Of particular concern, some industry speakers said, is a drop in presubmission meetings between ODE and sponsors. In many cases, ODE officials simply didn't have time to schedule them.

“The question we have to ask is, does [meeting the MDUFMA goals] achieve the original intent?” asked Marlene Valenti, vice president of regulatory affairs for Cordis Corp. (Miami), who spoke on behalf of AdvaMed. “In some cases, yes, but in some cases, with unintended consequences. Industry would . . . say that the objective is very infrequently met.”

In fact, she said, ODE has dramatically increased the number of “Not Approvable” letters for PMA applications and “Not Substantially Equivalent” letters for 510(k) applications since the advent of the MDUFMA goals. That suggests that ODE is denying applications that require a long time to assess for safety and efficacy, rather than taking the extra time to review them completely.

FDA should heed Jack Lasersohn's advice. Lasersohn spoke at the Stakeholders Meeting on behalf of the National Venture Capital Association, which represents venture capitalists that fund emerging device companies. He pointed out that MDUFMA goals should strive to make the entire regulatory pathway shorter, not just the time from submission to review decision.

“It's very important to not merely focus on goals simply because they are measurable,” he said. “For venture-backed industry, the biggest concern is not how fast things are completed at the end of the cycle, but how long the entire PMA process takes. Shaving 10–20 days off the end of a five-year process that costs $40 million–$50 million is a reasonable goal, but it only affects 1–2% of the total cycle time,” he said. “We ask you to try to focus on qualitative goals. It is important that we don't have a result that produces the wrong decision more quickly, which results in our members spending endless cycles to fix it.”

It's human nature to devote more attention to goals that you have an incentive to reach. The vast array of quantitative decision-time and cycle-time goals specified in MDUFMA led ODE to focus substantial energy on meeting them. The office should be commended for achieving the vast majority of them. But if that achievement comes at the expense of other valuable work, and causes the office to lose sight of presubmission time frames, then the system needs to be reevaluated. FDA, Congress, and industry must do a better job of looking at the big picture when reauthorization time comes.

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