July 21, 2026
Every five years, the FDA amends the Medical Device User Fee Amendments (MDUFA) agreement. If passed, this would become the sixth version of the Medical Device User Fee and Modernization Act of 2002, with the purpose of allowing regulators and industry representatives to negotiate updates to the program, which collects fees from applicants to fund FDA review.
The newly proposed MDUFA VI is not law yet, and is still subject to public commentary meetings, a final commitment letter to Congress, and Congressional approval. At this stage, all portions of the new amendment are still subject to change.
What's In the Proposed Agreement:
Accelerated Review Timelines for Particular FDA Applications
The new amendment includes faster pre-submission timelines with a written response within 45 days of receipt, as part of the Focused Follow-Up Pre-Submissions program. This has a planned roll-out for December 30th, 2027.
The FDA is also proposing an accelerated timeframe for structured De Novo introduction meetings. The FDA will meet with De Novo applicants within the first 30 review days. This new timeline will apply to applicants submitted on or after October 1st, 2027.
For products on the 510(k) pathway, the agreement's FY2028 goal is 128 calendar days, a temporary step back from the 112-day standard already in place today, with the timeline working back down to 112 days by FY2032.
Parallel Market Applications
Also included is a proposed International harmonization pilot program for concurrent device submissions to the FDA and at least two other regulatory bodies. This is especially beneficial for brands looking to expand their devices into multiple markets, such as the EU, Asia, or Australia. One thing to note with this program: the FDA retains final authorization decisions but can rely on an abridged data approach, leaning on other trusted regulators.
Digital Healthcare Technology Products
More broadly, MDUFA VI proposes to expand on the previous version's commitment to expedited approval of digital health products. The main goal of this initiative is to align the agency's review cycles with the life cycles of healthcare software products. The agency aims to expand its technical expertise to address rapidly evolving digital health technologies. Within this, the agency is also planning to transition the Total Product Life Cycle Advisory Program (TAP) from pilot to full program status. The TAP program will increase engagement with the Centers for Medicare & Medicaid Services to coordinate on approved healthcare technologies.
Increase in Technical and Scientific Staff
To support the initiatives and expedited review processes proposed in this agreement, the FDA intends to expand its technical and scientific staff. The agency will rely on user fees to hire more device submission reviewers and contractual support.
The Rollout Timeline
The first public review meeting is scheduled for August 5, 2026. The FDA will send its final commitment letter to Congress by January 15, 2027. The Congressional deadline to approve or reject the new amendment is September 30, 2027, when MDUFA V expires.
What This Means For the Industry
The immediate benefit for companies intending to submit applications for their products on or after the affected dates is a generally quicker review process, enabling a wider variety of medical devices to reach the market. The fact that some of these will include life-saving technology means that patients ultimately benefit from such healthcare innovation sooner.
For now, MDUFA VI remains a proposal, but it's one industry helped shape through the comment process, and one the FDA has real incentive to finalize on schedule, since MDUFA V funding lapses without it. Device companies planning submissions that could land near these effective dates, particularly the 2027 De Novo and Focused Follow-Up timelines, should start factoring the draft framework into their planning now, not after it's finalized. That's also worth a look for combination products where the device carries the primary mode of action, since CDRH's review process is exactly what's shifting here, separate from the drug-side manufacturing and registration requirements covered in our post on FDA's proposed drug manufacturing registration rule [link: insert once published]. We'll update this post as the agreement moves through the August public meeting and Congressional review, so the timeline here stays current as things develop.
Curious how a faster review pathway or the new De Novo meeting structure could affect your own submission timeline? Accorto's regulatory strategy team can walk through what MDUFA VI means for your specific product plans.
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About Accorto Regulatory Solutions
Accorto Regulatory Solutions, LLC is a U.S.-based regulatory consulting firm specializing in FDA regulatory strategy, application development, and compliance support for FDA-regulated products. Accorto works with companies at all stages of growth, from early-stage and startup organizations to established international manufacturers entering or expanding within the U.S. market. With experience across emerging and mature regulatory environments, Accorto helps clients translate regulatory requirements into practical, scalable solutions that support product development, market entry, and long-term compliance.
