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# Legislative MDUFA 4 Changes
- URL: https://www.fdaweb.com/legislative-mdufa-4-changes/
- Published: 2016-10-27T12:00:00.000Z
- Updated: 2026-09-14T21:43:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137192

New funding to be phased in over the course of MDUFA 4 will be used to implement proposed MDUFA 4 enhancements. A [summary](http://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526532.pdf?ref=fdaweb.com) of draft recommended legislative changes dated 10/25 shows new funding of $47,419,400 in FY 2018, $54,849,400 in FY 2019, $64,339,400 in FY 2020, $76,563,400 in FY 2021, and $77,313,400 in FY 2022\. The amounts will be adjusted for inflation each year, the document says.

Proposed statutory changes to implement the agreement include: 

- increasing the premarket notification submission fee from 2% of the PMA fee to 3.4%;
- reducing the fee small businesses pay for a premarket notification submission from 50% of the standard fee to 25%;
- establishing a fee to be collected for *de novo* classification requests equal to 30% of the PMA fee; and
- providing that *de novo* classification requests from small businesses are eligible for a reduced fee of 25% of the standard fee.

The draft also includes wording to implement the agreement provisions negotiated by the parties.