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# RWE, 510(k) TTD Discussed in MDUFA 6 Reauthorization
- URL: https://www.fdaweb.com/rwe-510-k-ttd-discussed-in-mdufa-6-reauthorization/
- Published: 2026-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:30:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160449

Among the topics discussed at the 12/11/2025 FDA/Industry MDUFA 6 Reauthorization Meeting were the FDA perspective on reauthorization involving real-world evidence (RWE) and the agency’s perspective on reauthorization of the 510(k) total time to decision (TTD) goal and methodology. According to the meeting [minutes](https://www.fda.gov/media/190452/download?attachment&ref=fdaweb.com), the agency’s RWE proposal outlined six key areas where both real-world data and RWE provide value on the regulatory evidence generation ecosystem:

- generating hypotheses early in development by identifying clinical needs and potential treatment effects;
- informing clinical trial design through refined eligibility criteria and endpoints while improving efficiency;
- serving as control arms when traditional randomization is challenging;
- providing infrastructure for pragmatic clinical trials through registries and electronic health records systems;
- supporting post-authorization studies to collect long-term performance information in real-world populations; and
- enabling indication expansions that bring improved technologies to patients.

FDA outlined its three focus areas for MDUFA 6: infrastructure and methods development; expert review and knowledge management; and FDA public engagement and reporting for transparency.

The agency’s perspective on the 510(k) TTD goal and methodology recommended simplifying the TTD calculation by using median time rather than average, which would be less sensitive to outliers and could support more realistic goal timelines. FDA also presented several alternative options and noted that effective performance goals must balance encouraging best practices with establishing realistic timelines that maintain staff motivation and system credibility.

The minutes indicate that industry representatives proposed establishing a working group to address TTD challenges beyond the options presented by FDA. The agency representatives agreed with this proposal.

Also discussed at the session was industry feedback on topics from the previous meeting, FDA’s perspective on the total product lifecycle advisory program, and industry’s interest in understanding the current staffing levels in MDUFA 5 compared to the expected staffing levels at the end of MDUFA 5.