CBSA and our national partners support the renewal of the critically important Medical Device User Fee Amendments (MDUFA). After months of negotiations among the FDA and industry advocacy groups, including AdvaMed and MDMA, an initial agreement to renew the fees was submitted to Congress last month. Without Congressional action, MDUFA would expire in September. CBSA supports policies that lead to greater consistency, predictability, and transparency in the Food and Drug Administration’s (FDA) review programs and help to bring safe and effective innovative therapies and technologies to patients.

Agreement Background

Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, whenever they submit an application or a notification to market a new medical device. These fees help the FDA increase the efficiency of regulatory processes with the goal of reducing the time it takes to bring safe and effective medical devices to the market. Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA) and the fees have been renewed in 2007, 2012, and 2017.

New Agreement Reached

Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees from 2023 to 2027. That number could increase to $1.9 billion with add-on payments if certain performance goals are met during that period. With these additional funds, the agency would be able to hire up to 114 more staff members in addition to the 273 new employees guaranteed under the agreement. Other agreement highlights include:

• Decreasing existing wait times for 510(K) clearances and PMA approvals by 20 days.
• Establishment of clear pre-submission goals that will reduce the total time to issue FDA decisions for medical devices.
• And new policies on carry-over balances and unused funds.

With the agreement sent to Congress and the hearing process started in both chambers, CBSA’s focus is now on advocacy related to any riders for the legislation that would be beneficial to members and the ecosystem.