The MDUFA V 60-Day Meeting Materials Rule

1. Key takeaways

MDUFA V contains a 60-day rule: applicants must submit their meeting materials within the 60 days preceding the meeting request. According to the MDUFA V terms set out in 90 FR 35895, where the materials are not submitted within that deadline, the relevant fee reduction does not apply. The rule converts early material preparation from good advice into a financial necessity: a meeting that proceeds on late materials can still take place, but the company pays for it without the reduction it might otherwise have obtained.

• Meeting materials must be submitted within the 60 days before the meeting request, under the MDUFA V terms.
• The consequence of late materials is loss of the applicable fee reduction, not cancellation of the meeting.
• The governing document is Medical Device User Fee Rates for Fiscal Year 2026, 90 FR 35895, published 2025-07-30.
• The rule is distinct from the 90-day submission-to-distribution interval that governs 510(k) planning.

2. Legal basis

The 60-day rule sits inside the MDUFA V terms published with the annual user fee notice, alongside the program pages that describe the submission formats used to prepare and file Q-Sub materials. The references below cover the rule itself, the PreSTAR vehicle, and the statutory framework.

3. Expert insights

Insight 1: The 60-day rule affects fee reduction eligibility, not whether the meeting can be held.

The legal consequence of the rule falls on the applicability of the fee reduction. In other words, even where materials are submitted late, the communication itself can still proceed, but the relevant fee reduction no longer applies. This is precisely why the rule belongs in the category of fee compliance rather than procedural compliance: the sanction is monetary, delivered through the fee schedule, rather than the refusal of a meeting. Companies that treat the deadline as an administrative detail may find that their meetings happen as planned while their fee savings quietly disappear, which makes the rule easy to miss in a retrospective cost review and difficult to recover once the fiscal year has closed.

Insight 2: The 60-day rule couples directly with Q-Sub scheduling.

A Q-Sub meeting request requires a complete package of materials prepared in advance. Working backwards from the 60-day requirement, the actual preparation work must be finished two months before the date of the meeting request. For high-risk projects such as De Novo requests and PMAs, this means that material preparation and Q-Sub scheduling must be managed in parallel rather than sequentially: the project plan needs a material completion date that is independent of the submission milestones, because the fee consequences attach to the material date, not to the filing date of the underlying submission. Companies running several Q-Subs in the same quarter should stagger their material completion dates so that every meeting request is supported by a package that finished inside its own 60-day window, with the timestamp evidence archived at the moment of submission.

Insight 3: PreSTAR can serve as the vehicle for preparing the materials.

According to FDA’s eSTAR Program page, PreSTAR covers six types of Q-Sub. Preparing materials through PreSTAR aligns them directly with FDA’s internal templates, which reduces the volume of deficiencies and supplemental requests during review. For companies that file Q-Subs regularly, standardizing on the PreSTAR format shortens internal drafting cycles as well, since the template imposes a stable structure on the material package before the 60-day clock starts running. Teams that draft directly against the template also spend less time reworking sections that FDA reviewers would otherwise return, and the material package reaches its final form earlier in the window.

Insight 4: The 60-day rule and the 90-day submission period are two different time references.

The 90-day period attached to the 510(k) is the interval from submission to planned commercial distribution, under FD&C Act Section 510(k). The 60-day rule, by contrast, is the interval between the meeting materials and the meeting request. The two clocks constrain different stages of the regulatory pathway and cannot be merged into one calculation. A project plan that tracks only the 90-day period will leave the 60-day material deadline unmanaged, and the fee reduction attached to timely materials will be lost even though the submission timeline itself looked healthy.

4. Practical recommendations

The measures below embed the 60-day rule into project planning so that fee reduction eligibility is protected by design.

• Start material preparation 60 days before the meeting request, and set the material completion date as an independent project milestone.
• Use the current version of PreSTAR (3.1) to prepare Q-Sub materials.
• List the 60-day rule and the 90-day submission period separately in the project Gantt chart, marked in different colors.
• Organize the material package according to FDA’s internal templates to reduce pre-meeting deficiencies.
• Retain timestamp evidence of the material submission as support for fee reduction eligibility.

5. Verification checklist

Confirm each item below before filing a meeting request that is intended to carry a fee reduction.

• □ The material preparation plan has been scheduled backwards from the 60-day requirement.
• □ The material completion date has been set as an independent milestone.
• □ The current version of PreSTAR (3.1) has been used for preparation.
• □ The 60-day rule and the 90-day submission period have been entered separately in the Gantt chart.
• □ Timestamp evidence of the material submission has been retained.
• □ It has been confirmed whether the meeting qualifies for the applicable fee reduction.

Regulatory information verified as of October 28, 2026.

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