Medical device industry trade groups and the U.S. Food and Drug Administration reached a tentative agreement designed to speed up and improve the agency’s review process as part of the third reauthorization of the Medical Device User Fee Act or MDUFA.

“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,” says Stephen Ubl, president and CEO of trade group Advanced Medical Technology Association, also known as AdvaMed. “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 agreement in principle, a result of more than a year of negotiation, includes authorization for the FDA to collect $595 million in user fees over five years, double the $287 million collected during the previous five years.

It will allow the FDA to hire more than 200 additional employees and result in a reduction in average total review times, says the agency, and result in greater accountability, predictability, and transparency through such improvements as a more structured pre-submission process and earlier interactions between FDA and applicants.

“Reauthorization of this important program is an essential component for advancing medical device innovation,” says FDA Commissioner Margaret A. Hamburg.

Besides reduction of review times for premarket applications and 510(k) submissions, the new agreement provides for the FDA to meet with applicants halfway through the review process to give them time to respond to reviewers questions. It also includes a leave “no submission behind” provision requiring FDA to meet with companies if a performance goal on a premarket application or 510(k) is missed and work out a plan for completing work on the submission.

The industry associations involved in the negotiations include AdvaMed, the Medical Device Manufacturers Association, and the Medical Imaging and Technology Alliance.

The biopharmaceutical industry has also negotiated a tentative agreement with regulators for its upcoming reauthorization of its own user fee rules—PDUFA—which is set to be renewed at the end of September. The House Energy and Commerce health subcommittee is currently conducting hearings to look at the agreement, which was made public in September 2011, and asks drugmakers for new higher fees over the next five years to facilitate the review process for new drugs.

The user fee program for medical device makers was established by Congress 10 years ago with the Medical Device User Fee and Modernization Act of 2002, prompted by growing concerns about the capacity and performance of the medical device review program. The five-year program was reauthorized in 2007 and is set to expire on September 30. It authorized FDA to collect user fees for certain medical device applications, for the registration of certain medical device establishments, and for certain other purposes. Small businesses could have their fees waived on certain submissions or qualify for a reduced fee.

The proposed agreement on MDUFA III must still be approved by Congress, which has until the end of September to act. AdvaMed will work with members of Congress, FDA, and other stakeholders to help make sure the agreement wins approval before the September 30 deadline, says Ubl.