Perhaps most important to the industry is the way those review time goals will now be handled. Previously, the FDA's goals were centered on "FDA days" -- meaning the number of days the FDA spent reviewing the product, typically set at around 90 days for a device cleared in the 510(k) pathway, which includes much new imaging equipment. However, the 90 days only applies to the time the FDA spends reviewing the data; if the agency asks for more information, which often happens, it pauses that countdown, even as the actual calendar days fly by.

Now, the new plan also calls for the agency to commit to a reduction in average total review time -- that is, the time from the filing of the application to the final decision from the agency.

"We think that will have the net effect of reducing total review time, the most important measurement you can make," Ubl said.

On the call, Janet Trunzo, AdvaMed's executive vice president, technology and regulatory affairs, who helped lead the negotiations with the FDA, said the process would ramp up from fiscal 2013, when the new rules take effect, to fiscal 2017, the end of the proposed program. By 2017, for instance, the final average total for a 510(k) would be 124 calendar days, she said.

More staff

On the FDA's end, the agreement gives the agency $595 million over the next five years, a boost over the $287 million it was earmarked through the program in the last reauthorization, although less than the $800 million or so the agency was originally asking, according to minutes of meetings hosted on the agency's website.

One use of the money will be increasing staff: in an announcement, MITA said the agency would hire 200 new full-time-equivalent workers, including 140 device reviewers, with the aim of also lowering the ratio of managers to reviewers at the agency.

However, although the deal was approved in principle by the trade groups and by the agency, details, such as fee structure, have to be worked out. The deadline for finalizing the agreement is Sept. 30, when the five-year program's last reauthorization expires and needs to be renewed.

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