MDUFA V Proposed Recommendations for Reauthorization Ready for Public Meeting

03/29/2022

The US Food and Drug Administration (FDA) published a press release confirming that the FDA and medical device industry stakeholders reached an agreement on proposed recommendations for the fifth reauthorization of the Medical Device User Fee Amendments of 2023 (MDUFA V). The first authorized user fee for medical device occurred with the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add:

  • User fees for premarket reviews of Premarket Approvals (PMAs), Premarket Notification (510(k)), and other applicable applications (current fee breakdown HERE)

  • Performance goals for premarket reviews

  • Establishment inspections by accredited individuals

The proposed performance goals and procedures for MDUFA V are described in the draft here. MDUFA IV is authorized through September 2022. Due to the pandemic and extended industry discussion about the proposed recommendations, the January 15, 2022 deadline to send MDUFA V to Congress was missed.

Similar to MDUFMA and MDUFA, the Prescription Drug User Fee Act (PDUFA), first passed in 1992, collects user fees from sponsors for New Drug Applications (NDA) or Biologics License Applications (BLA). The fees from MDUFA and PDUFA supplement the money budgeted for the FDA by Congress for regulatory review of applications and help to expedite the approval process. Each year the fees are adjusted for inflation, workload, and other applicable adjustable costs. Every five years, MDUFA and PDUFA must be reauthorized. PDUFA VI of 2017 is currently reauthorized through the Food and Drug Administration Reauthorization Act (FDARA) until September 2022. Information about PDUFA VII reauthorization is posted here.

A virtual public meeting is planned for April 19, 2022 to provide an opportunity for attendees to learn about the proposed recommendations and to comment on them. Meeting information will be added to this page under the “MDUFA V Public Meetings” header. The FDA will consider the comments for revision to the draft and then send the final recommendations to Congress later in April 2022.

 

- The Clinical Pathways Team

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