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# Device User Fee Negotiations at Standstill
- URL: https://www.fdaweb.com/device-user-fee-negotiations-at-standstill/
- Published: 2022-01-18T12:00:00.000Z
- Updated: 2026-09-14T17:28:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150951

FDA and the medical device industry have reportedly come to a standstill in their negotiations on the next five-year iteration of the medical device user fee agreement. A 1/15 deadline to submit their negotiated final commitment letter to Congress has come and gone without the two parties budging in either direction. The packages for prescription drugs. biosimilars, and generic drugs were transmitted to Congress on time.

Industry and FDA negotiators remain about $1 billion apart in their proposals, and the two sides have reportedly not had talks since Thanksgiving, according to a [report by ](https://www.mystrategist.com/market-pathways/article/device%5Fuser%5Ffee%5Ftalks%5Fstalled%5Fas%5Fa%5Fdeadline%5Fapproaches.html?ref=fdaweb.com)[*Market Pathways*](https://www.mystrategist.com/market-pathways/article/device%5Fuser%5Ffee%5Ftalks%5Fstalled%5Fas%5Fa%5Fdeadline%5Fapproaches.html?ref=fdaweb.com)*.* Once a deal is reached on device user fees, the commitment letter is posted for a 30-day public comment period and public stakeholder meeting must be convened before it can be sent to Congress.

Without the two sides meeting at the moment, a device user fee agreement is all but imminent. Late last year, industry trade groups offered an updated user fee proposal of about $1.4 billion over five years, which is a significant departure from the $2.5 billion in fees included in FDA’s proposal, according to the report. The device industry is calling for a “back to basics” approach that is intended to provide enough funding and staffing to support FDA regaining pre-Covid-19 performance levels, but shying away from funding any new significant programs or initiatives tied to user fees. Meanwhile, the report says the agency is pushing hard for its [TPLC (Total Product Lifecycle) Advisory Program (TAP) proposal](https://www.mystrategist.com/market-pathways/article/jeff%5Fshuren%5Fon%5Ffda-sponsor%5Fengagement%5Fwhere%5Fits%5Fbeen%5Fand%5Fwhere%5Fits%5Fgoing%5F.html?ref=fdaweb.com), which would dedicate additional user fee funding to launch a concierge-style approach for participating devices. The two sides are also divided on how FDA handles carryover funds that are left over at the end of each fiscal year. 

FDA wouldn’t comment specifically about the ongoing negotiations. “When our negotiations have been finalized, we will be communicating with the public about the status of the agreements reached through the MDUFA negotiation process,” an agency spokesperson is quoted in the report as saying.

There is still plenty of time as the user fee programs do not sunset until 10/1, and delayed negotiations caused the agency to miss other user fee commitment letter submissions in the past, while still working out final details ahead of the 10/1 expiration date.