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# FDA Reports Progress in MDUFA 6 Negotiations
- URL: https://www.fdaweb.com/fda-reports-progress-in-mdufa-6-negotiations/
- Published: 2026-02-10T12:00:00.000Z
- Updated: 2026-09-14T13:33:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160640

Minutes from the 1/21 MDUFA 6 reauthorization meeting indicate progress is being made in several areas. The [minutes](https://www.fda.gov/media/191027/download?attachment&ref=fdaweb.com) say industry representatives gave their feedback on real-world evidence (RWE), saying they support the National Evaluation System for Health Technology (NEST) and emphasizing that NEST Mark is potentially an important future tool for evaluating RWE quality. Industry said collaboration appears to be going well and requested more specifics on FDA’s proposed RWE investment regarding the full-time equivalents and operational dollars to understand how the funds will be spent, explain more detail on data sources that would be leveraged and how they translate to premarket review, and what current FTEs are doing in RWE at this time. FDA said it will work to provide the requested information.

Areas of agreement and areas needing more discussion involving *de novo* and the presubmission programs were discussed.

There was agreement on a set of 510(k) total time to decision goals and on a way to move forward on the agency’s international harmonization proposal.