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There are some notable program updates in the latest device user fee agreement regarding Pre-Submissions and “America First” fees, but the draft MDUFA VI framework presented at FDA headquarters this week is much more about stability than disruption.
The Medicare agency finalized plans to cancel its “alternative pathway” to new technology add-on and device pass-through payments for FDA Breakthrough Devices. However, it agreed to add a transitional period allowing firms to access the streamlined route for the next two years if they get a breakthrough designation by September.
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in August 2026. Updated August 13.