New Medical Device User Fee Agreement Will Improve FDA Performance, Provide Accountability, Predictability

New Medical Device User Fee Agreement Will Improve FDA Performance, Provide Accountability, Predictability

Deal Sets Important Goal For Total Review Times

WASHINGTON, D.C. - The Advanced Medical Technology Association (AdvaMed), along with other medical device trade associations, and FDA today announced a tentative agreement on a series of strong, measureable performance goals that will improve the agency's medical device review process as part of the reauthorization of the "Medical Device User Fee Act."

"The tentative new user fee agreement puts in place a framework that will benefit FDA and industry, but most importantly patients by accelerating the development and approval of safe and effective treatments and diagnostics," said Stephen J. Ubl, AdvaMed president and CEO. "The improvements in the agreement provide FDA and medical technology companies the tools needed to improve the efficiency and consistency of the review process."

The robust performance goals agreed to by FDA and the trade associations call for the agency to:

· Achieve reductions in total review times, measuring from the time of submission to the time FDA makes a decision on a premarket application (PMA) or a 510(k) submission. The total time is the most meaningful measure of the approval process;

· Achieves significant performance improvements for premarket approval (PMA) and 510(k) applications relative to current performance;

· Leave "no submission behind" by requiring FDA to meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing work on the submission;

· Provide a substantive interaction with applicants halfway through the targeted time for completion of review, thus ensuring that a company can have time to properly respond to appropriate questions; and

· Implement an analysis of FDA's management of the review process by an independent consulting organization, coupled with an FDA corrective action plan to address opportunities for improvement.

"AdvaMed looks forward to a productive working relationship with FDA under the agreement. The user fee agreement is not self-executing. It requires consistent and efficient administration by FDA leadership," Ubl said. "It is in the interests of patients and the American economy that this agreement functions well, and we will work with FDA to help make that happen."

Ubl thanked FDA Commissioner Margaret Hamburg, CDRH Director Dr. Jeff Shuren and other senior FDA leaders for their work on the agreement, and he praised the cooperation among the trade associations involved in the negotiations.

The agreement provides FDA $595 million in funds over five years, which will give FDA the ability to hire additional reviewers, lower the ratio of managers to reviewers and enhance training for reviewers.

Ubl said AdvaMed would work with members of Congress from both sides of the aisle, FDA and other stakeholders to help make sure the agreement wins approval before the Sept. 30 deadline. "We look forward to a meaningful dialogue with members of Congress about the agreement," Ubl said.