ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA schedules public launch meeting for MDUFA VI talks, and proposes to downclassify a category of companion diagnostics to 510(k) status; Medicare nationally covers respiratory assist devices; Brazil cancels upclassified IVD certifications; China issues guidance on next-generation sequencing classifications; South Korea details consultation procedures; and more.
FDA Picks
MDUFA meeting, companion diagnostics, and mesh devices:
MDUFA talks. FDA will open the MDUFA reauthorization process August 4 with a public meeting to discuss proposed recommendations for a renewed user fee program. The meeting, and an associated public comment period, is the precursor to FDA and industry initiating talks to negotiate a MDUFA VI reauthorization agreement. The parties need to finalize an agreement and Congress needs to enact it in legislation before September 30, 2027, when the current MDUFA V program expires. An early August date for the launch meeting, set in a notice published this week, is relatively consistent with when prior reauthorization negotiation cycles started (and it is several months ahead of schedule compared to the last time around when the process was delayed by COVID-19). That’s noteworthy after observers predicted the process might stall in the face of the April 1 “reductions in force,” which put many in-house FDA user fee program experts on administrative leave. Still, HHS leadership remains wary of user fees as a source of conflict of interest at the agency. In addition, the administration’s commitment to the resource arrangements at the core of user fee agreements might be questioned in the context of FDA’s FY 2026 budget request. It proposes cutting 200 full-time equivalent staff funded by MDUFA fees, even though fee income, as well as hiring commitments under MDUFA V, are on the rise. (For more on the budget request in Market Pathways, see “FDA Proposes Device User Fee Staff Cuts Amid Budget Increase.”)
