Blog: New Device User Fee Agreement a Potential Game Changer

The new user fee agreement between the medical technology industry and FDA is a potential game-changer. FDA’s medical device review process will get much-needed process improvements that will make the agency more efficient and accountable, and FDA will get new resources to meet the commitments in the agreement.

By way of background, the agreement – which must be approved by Congress – would continue the user fee program originally authorized in the “Medical Device User Fee and Modernization Act of 2002,” reauthorized in 2007, and now set to expire on September 30 unless Congress approves a new agreement.

The new agreement comes when many believe vast improvements are needed in FDA’s device review process. Even FDA itself has acknowledged that reviews have become inconsistent and inefficient. But the new agreement can change this trajectory because it includes a series of strong, measureable performance goals that should accelerate FDA’s decisions on premarket submissions for devices and diagnostics.

It is a win for the medical technology industry and a win for FDA, but most importantly, it is a win for patients who need life-changing, life-saving medical technology.

FDA’s  medical device review program will be improved in several key ways, including the following:

1) Making FDA responsible for total review time goals

The new total time goal in calendar days will measure the average time of submission to the time FDA makes a decision on the application. 

2) Significantly improved review times

The agency pledges to substantially shorten the number of FDA days it takes to make decisions on applications.

3) Process improvements that should improve the consistency and timeliness of the approval process independent of the specific time goals

•    Mid-submission review – Mandates a substantive interaction between FDA and applicants halfway through the targeted time for completion of a review.

•    No submission left behind – Requires FDA to meet with companies if the review goal is missed for 510(k) and PMA submissions and work out a plan for completing work on the submission.

•    Meaningful pre-submission interaction – FDA will not change commitments, except in rare circumstances, it has reached in pre-submission interactions.

4) Greater accountability

The agreement provides for improved transparency and greater accountability. New reporting tools and an independent analysis of the management of the review process will provide key data to track FDA performance, highlight any failures to meet key goals and provide the basis for corrective action.

5) Enhanced resources

The agreement provides for $595 million in user fees to FDA for 2013–2017. Additional reviewers, lower manager-to-reviewer ratio, enhanced training and other resources will give FDA what it needs to improve performance.

The agreement cannot implement itself, however. Success depends on consistent and efficient administration of the program, appropriate Congressional oversight, and a commitment from industry to work with FDA to make sure the goals of the agreement are achieved.

AdvaMed will continue to work with Congress, FDA and other stakeholders to help make sure the agreement, along with legislative reforms that increase the opportunity for success at the agency, wins approval before the September 30 deadline.

Janet Trunzo, is the executive vice president, technology and regulatory affairs, at AdvaMed. Additional information about AdvaMed can be obtained at its website.