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# 7 Topics Discussed at 2nd MDUFA 5 Reauthorization Meeting
- URL: https://www.fdaweb.com/7-topics-discussed-at-2nd-mdufa-5-reauthorization-meeting/
- Published: 2021-04-20T12:00:00.000Z
- Updated: 2026-09-14T16:55:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149149

At the second MDUFA 5 reauthorization meeting between FDA and industry, held on 3/17, seven items were discussed. A meeting [summary](http://www.fda.gov/media/147718/download?ref=fdaweb.com) lists the items as: 

- Stakeholder feedback on MDUFA reauthorization from a 10/27/20 public meeting;
- FDA perspective on MDUFA 4 performance, noting that the agency disagrees with industry’s characterization of aspects of FDA’s MDUFA 4 performance as “not being met or unlikely to be met;”
- MDUFA 4 financial information with an overview of total user fee target revenue across agency user fee programs that reported that while MDUFA 4 provided a meaningful increase in funds for the program, the combined total of user fees contributing to the human drugs program is more than seven times higher;
- FDA overview of digital transformation that described the current information technology infrastructure as outdated, fragmented, and inefficient and said the aging system has been slowing the regulatory process;
- Fully-loaded FTE (full-time equivalent) cost model methodology;
- Industry perspective on reauthorization stating these objectives and principles for MDUFA V: **(1)** timely patient access to safe and effective products; **(2)** identification of mutual goals and process improvements to achieve timely patient access; **(3)** retaining congressional appropriations as the primary source of CDRH funding, with user fees as additive; and **(4)** using fees solely for the premarket review process, and **(5)** recognition that industry has made significant and material investments under MDUFA 1-4; and
- FDA overview on recruitment and retention outlining efforts to address hiring challenges from FY 2018 and 2019.