As expected, Congress was able to pass a bill implementing the new Medical Devices User Fee Amendments agreement (MDUFA V) before the Sept. 30 deadline. The new deal provides the FDA a minimum of $1.78 billion in user fees from 2023 to 2027, which could increase to $1.9 billion based on the agency’s achievement of performance goals.
The agreement also includes funding for the FDA’s proposed Total Product Life Cycle (TPLC) Advisory Program (TAP) authorizing the agency to enlist physician advisors, private health insurers, and other outside stakeholders. While expanding agency perspective, such an investment will also significantly increase user fees. After initially opposing the plan, industry has reluctantly agreed to accept it—with stipulations. Rather than a comprehensive program, TAP was launched as a pilot program on Oct. 11. According to media sources, the program will be funded by $110 million in leftover MDUFA IV monies and $45 million from FDA base funding.
The pilot program will also include a mid-point assessment so that both industry and the FDA can evaluate the program’s effectiveness.
After passage of the MDUFA, the FDA announced the user fees for fiscal year 2023, which are effective October 1, 2022, through September 30, 2023. The registration fee will be $6,493 per establishment. The deadline to pay the fee is Dec. 31, 2022, and there are no waivers or reductions for small establishments, businesses, or groups. Other fees:
|Application Type||Standard Fee||Small Business Fee*|
|Premarket Approval Application (PMA), Product Development Protocol (PDP), Premarket Reports (PMR), Biologics License Application (BLA)||$441,547||$110,387|
|De Novo Classification Request||$132,464||$33,116|
|BLA Efficacy Supplement||$441,547||$110,387|
|Annual Fee for Periodic Reporting on a Class III Device (PMAs, PDPs, and PMRs)||$15,454||$3,864|
Source: U.S. FDA Medical Device User Fee Amendments (MDUFA). “User Fees for FY2023.”
See the full version of this article in the upcoming November 2022 issue of National Lab Reporter.