Are Medical Device Trial Approval Times Getting Shorter?

By Chuck Seegert, Ph.D.

Approval times for clinical studies are decreasing, according to the FDA’s deputy director of science. The FDA science executive spoke to members of a medical device advocacy group in a recent meeting, where he also discussed a review of the premarket approval (PMA) process that may reclassify devices, removing some from high-risk categories.

Regulatory approval for devices is commonly perceived to be a slow and unwieldy process. The FDA is making significant effort to improve this widely lamented state of affairs by targeting customer service aspects of the approval process. Additionally, the PMA process has remained relatively static since it was first put in place, which may mean that some of its classifications could benefit from review.

In an address to members of MassMEDIC, upcoming regulatory initiatives were discussed by Bill Maisel, M.D., deputy director of science at the FDA, according to a recent story by the Boston Business Journal. MassMedic is the Massachusetts medical device industry council, a group composed of medical device executives, legislators, and others interested in driving medical device growth in the state.

Improving response times has been an initiative for the agency over the last two to three years, according to the Boston Business Journal. To illustrate improvements in the FDA’s review times, Maisel claimed that there was a reduction of about 75 percent in the time it takes from submission of an application to run a trial to a decision on that application. In 2011, it took greater than 400 days for a clinical trial to be approved. Currently, the review time from submission to approval is only 101 days.

"We want patients in the U.S. to have access first in the world to the best technology," Maisel said, according to the Journal. "That means timely approval of trials."

A separate indicator of improvement, however, is a decreased backlog of submissions awaiting approval, Maisel noted in the Journal. This form of success has been supported by independent analysis.

“The FDA also proposed a so-called ‘Expedited Access PMA’ program which will allow for more interaction between the agency and companies that are developing products designated as high risk, but in areas in which significant need exists,” the Journal reported. “The program would be somewhat analogous to the FDA accelerated approval program for new drugs.”