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Source: and RRY Publications LLC

Higher User Fees, Faster FDA Review Times

Walter Eisner • Fri, August 11th, 2017

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FDA review times for device manufacturers should go down after the U.S. Senate voted 94-1 on August 3, 2017 to reauthorize the FDA's user fees agreement for another five years.

The biggest changes to the previous user fee agreement is that device manufacturers will see an increase of more than $320 million in user fees over the next five years. In exchange, the FDA has agreed to reduce the average total time to decisions for premarket approval applications (PMA) and 510(k) submissions, among other provisions. Currently, medical product user fees cover an average of 60% of FDA premarket review costs.

Review Goals

For 510(k) products, the total time goal is currently 124 days. The MDUFA (Medical Device User Fee Act) IV agreement lowers that goal by 13% to 108 days by the fifth year.

For PMA products, the total time to decision goal is currently 385 days. The MDUFA IV agreement lowers that goal by 25% to 290 days by the fifth year.

And for the first time, the MDUFA IV agreement includes goals for de novo products, which are generally moderate risk products but brand new innovations, which FDA has never evaluated before.

The FDA Reauthorization Act (FDARA) of 2017 includes the fourth iteration of the Medical Device User Fee Act.

The device industry's trade association, AdvaMed, was happy. "Passage of this important legislation will enable FDA to continue its critical mission of ensuring safe and effective medical devices and diagnostics remain available to patients everywhere," stated a company press release.

“The robust FDA performance goals, process improvements, increased accountability and additional resources provided for under the new user fee agreement represent a victory for the agency, innovation and, most importantly, patients. The bill also includes pro-innovation provisions to improve the FDA inspections process and streamline device accessory classification."

Speaking in support of the legislation at a Congressional hearing, AdvaMed President and CEO Scott Whitaker said the MDUFA IV agreement will lead to timelier patient access to devices.

Whitaker noted that total time goals were first included in MDUFA five years ago, and have been a meaningful measure for both industry and FDA. "Building on the total time goal, this MDUFA IV agreement will continue to drive towards reducing the total time that is spent reviewing a submission."

It was expected that the President would sign the bill. The White House had urged Congress to require device and drug makers to pay 100% of the costs for evaluating and approving products into the marketplace. The Senate declined to accept that recommendation.

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