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The reauthorization of the Medical Device User Fee Amendments (MDUFA) brings more pressure for FDA to shorten its review times back to “historical norms” and to provide more consistency in the review process. And after the success of an independent review authorized in MDUFA III in 2012, MDUFA IV has authorized two independent reviews of the agency over the next five years. Total funding for the five-year agreement is $999.5 million.

Under the new agreement, the average total time to decision for 510(k)s will drop to 108 days by the fifth year of the program (FY 2022). “That brings it back to historical norms from about a decade ago,” says AdvaMed’s Janet Trunzo, senior executive vice president for technology and regulatory affairs. For PMAs, the average total time goal will be reduced to 290 days, a 25% decrease from the current benchmark.

A new goal for the presubmission process is for FDA to provide feedback at least five days before a scheduled presubmission meeting. In the past, feedback has been received as late as the night before the meeting.

A number of changes in MDUFA IV came from the independent assessment authorized under MDUFA III conducted by management consulting firm Booz Allen Hamilton. One significant recommendation calls for FDA to implement a quality management system (QMS) approach to the device review process. A QMS unit will conduct audits to identify areas for improvement.

“The role of an outside observer for improving the review process cannot be underestimated,” said Trunzo, which is why she says the MDUFA IV agreement funds two additional outside assessments of the review process.

The new agreement also includes process reforms related to the deficiency letters FDA often sends to product sponsors during the review process. All deficiency letters will now include a reference to the basis for the deficiency determination, citing specific language from a regulation, guidance document, or standard. All deficiency letters will also undergo supervisory review.

Trunzo says this reform is designed to build more consistency and predictability into the review process. “One of the areas that was identified in the independent assessment under MDUFA III is that the additional information requests needed greater consistency. And the one way to do it is to provide a citation as to the basis for the additional information that is being requested.”

Also included in the agreement is funding for a three-year project to assess whether real-world evidence can be used effectively to support premarket review activities.

“The end result is a win for patients who will have more timely access to technology. It will be a win for FDA to fulfill its mission, to not only protect the public health, but promote medical advancements. Finally, it’s a win for innovation as there will be greater efficiency and predictability in the agency’s review processes,” says Trunzo.

Sherrie Trigg, Editor and Director of Medical Content