MDUFA IV to add $50-75 Million Annually in new User fee Revenue for FDA

The US Food and Drug Administration (FDA) on Tuesday proposed increasing user fees for medical device manufacturers by more than $320 million over the next five years, according to a draft proposal for MDUFA IV.

The new funding will enable FDA to implement a number of proposed enhancements, with additional funding (amounts will also be adjusted for inflation each year) to be phased in over each fiscal year (FY) as follows:

• $47,419,400 for FY 2018
• $54,849,400 for FY 2019 ($7,430,000 above the FY 2018 level)
• $64,339,400 for FY 2020 ($9,490,000 above the FY 2019 level)
• $76,563,400 for FY 2021 ($12,224,000 above the FY 2020 level)
• $77,313,400 for FY 2022 ($7,500,000 above the FY 2021 level)

Specifics

FDA and industry representatives, according to the draft commitment letter, said they “agree that the process improvements outlined in this letter, when implemented by all parties as intended, should reduce the average Total Time to Decision for PMA applications and 510(k) submissions.”

In addition to the increase in fees, FDA will look to advance patient input and involvement in the regulatory process; strive to finalize, withdraw, reopen the comment period or issue a new draft guidance for 80% of draft guidance documents within three years of the close of the comment periods; improve the third party review program with a goal of eliminating routine re-review by FDA; support the National Evaluation System for health Technology (NEST) by hiring FDA staff with expertise in the use of real world evidence; streamline and align FDA review processes for Software as a Medical Device (SaMD) and software inside of medical devices (SiMD); establish an Accreditation Scheme for Conformity Assessment (ASCA) Program using FDA-recognized consensus standards; and report its progress toward meeting these goals.

Industry group AdvaMed, meanwhile, praised the recommended changes, noting the process improvements, highlighting commitments "to providing meaningful written feedback to companies at least five days prior to a scheduled pre-submission meeting. The agency also will update its guidance on the pre-submission process. In addition, for the first time, FDA will be required to document the scientific rationale for issuing a deficiency letter to a sponsor."

The National Health Council (NHC) said Wednesday it commends FDA on the proposal and that the increase in industry user fees "should help get safer and more effective devices to patients faster."

Summary of Draft Recommended Changes to Statutory Language for MDUFA IV

Draft MDUFA IV Commitment Letter