FDA Releases Draft Commitments Letter for Medical Devices Review, Public Meeting Scheduled

The U.S. Food and Drug Administration (FDA) published a notice in the Federal Register on July 7, 2026, announcing the availability of the draft commitments letter for the Medical Device User Fee Act (MDUFA) reauthorization. The draft commitments letter outlines policies and procedures for medical devices at all stages as agreed upon by the FDA and medical device industry, which have met regularly for more than a year. The public meeting on the draft commitments letter will take place on August 5, 2026. 

Where User Fee Acts Are Today

The process to reauthorize MDUFA happens every five years. (See Holland & Knight's previous alert, "FDA User Fee Act Reauthorization: What Happens Next and Positioning for Possible Reform," March 11, 2026.) Publication of the commitments letter and public hearing that follows mark a step toward the transmission of a formal agreement to U.S. Congress for its consideration, which the U.S. Department of Health and Human Services (HHS) Secretary is required by statute to submit no later than January 15, 2027. However, Congress is not wasting any time or waiting to receive the final agreement before beginning its own work on MDUFA: The U.S. House of Representatives Committee on Energy and Commerce Subcommittee on Health will hold an educational hearing on the user fee reauthorization process on July 15, 2026.

Overview of Draft Commitments Letter

Timelines for Remaining Marketing Pathways Remain Largely Unchanged, With Exception of New Feature for Pre-Submission

The draft commitments letter largely retains existing timelines for FDA tasks, including the provision of feedback, completion of reviews and issuance of determinations on submissions based on marketing pathway for fiscal year (FY) 2028 to FY 2032. Requirements are also retained for the Center for Devices and Radiological Health (CDRH) to report quarterly and the Center for Biologics Evaluation and Research to report annually on all aspects of MDUFA.

However, there are notable recommendations outlined in the commitments letter to improve and enhance transparency, communication and coordination within HHS and with foreign regulatory authorities, which would represent new features of MDUFA. An overview of the major portions of the draft commitment letter is below.

New Feature for Pre-Submissions

The FDA will continue the Pre-Submission program (including the Q-Submission program), with a notable recommendation to include a new, second submission feature called "Focused Follow-Up Pre-Submission," which will begin by December 30, 2027. Pre-Submission requests allow for formal, written feedback prior to formal 510(k) or Premarket Approval submission to guide product development, align with FDA practices or support predicate selection. For new Focused Follow-Up Pre-Submissions, the FDA will provide written responses within 45 calendar days of receipt. This provides sponsors an opportunity to receive additional FDA feedback on specific questions prior to submission of a review application. According to the Federal Register notice, Focused Follow-Up Pre-Submissions will include payment of a fee, which will be treated by FDA as a credit toward a certain related, subsequent marketing submission fee if accepted. The FDA will provide written feedback on Traditional Pre-Submissions requests within 70 calendar days of receipt or five calendar days prior to a scheduled meeting, whichever is sooner, for 90 percent of Pre-Submissions up to 5,000 submissions.

Throughout the draft commitments letter, the FDA consistently emphasizes the importance of interactive communication between the FDA and applicants, including on potential deficiencies, to ensure submissions are not placed on hold. Existing timelines for most reviews and decision issuances are retained, varying across marketing pathway.

The FDA's decision goals range from 180 FDA days for 90 percent of submissions for Original Pre-Market Approvals that do not require Advisory Committee input, to 150 FDA days for 90 percent of de novo requests, to 90 FDA days for 95 percent of 510(k) submissions. The FDA will review and act on Biologics License Applications (BLAs) on certain timelines, dependent upon whether a submission is designated as either standard or priority, with FDA decision goals for original BLA submissions or efficacy supplements being 10 months of receipt for 90 percent of submissions, or six months for priority submissions or efficacy supplements.

Financial Transparency and Carryover Balance

To support transparency into potential changes in medical device application costs such as personnel compensation and the volume of appropriated user fee funds in the operating reserves, the FDA will issue a MDUFA five-year financial plan no later than March 31, 2028, with updates to the five-year plan published at the end of each FY thereafter.

The FDA will retain eight weeks of operating reserves and reduce registration fees for the following FY, should an amount equivalent to 15 weeks of operating reserves be exceeded. Conversely, the FDA will increase registration fees if operating reserves fall below an amount equivalent to eight weeks of operating reserves to cover two-week intervals until an eight-weeks operating balance is restored. Adjustments to registration fees will only be made if collections fall or other factors occur "beyond agency control." Though not significant in terms of impacting operating reserve volume, the inclusion of this language is a departure from the most recent MDUFA and appears to reflect industry concern regarding significant reductions in force, which impacted FDA staff and represents an agreement with industry to maintain review staff levels.

Information Technology and Communication Enhancements

The FDA will maintain and improve upon the Customer Collaboration Portal, which allows manufacturers to electronically submit and track certain submissions. By September 30, 2030, the FDA will also develop an "optional, user-friendly, interactive navigator tool" to support stakeholder needs and communications, with tools developed in the interim being made available "where feasible." The FDA will also create electronic submission templates for voluntary use (unless otherwise required), with a De Novo Pre-Submission template to be developed and completed by September 30, 2029.

In addition, the FDA will further develop its Resource Capacity Planning and Management capability to support review process capacity in line with MDUFA performance commitments. The FDA will publish an implementation plan no later than March 31, 2029, detailing milestones and progress reporting, as well as an annual summary beginning FY 2030.

In line with the FDA's emphasis on the importance of interactive review, clear communication regarding deficiencies and the consistency of reviews, the FDA will schedule and hold staff/manager training on best practices for clear deficiencies communication by September 30, 2028. The FDA will also develop a survey for recipients of deficiency letters by September 30, 2029, and administer the survey to a representative sample by March 31, 2030. Continued support for third-party review is also stated.

External Stakeholder Engagement and RWE

In the letter, the FDA commits to regular engagement with patients and other external stakeholders and highlights the potential for data sources such as real-world evidence (RWE) to support product applications, as well as data that reflects the use of innovative technology in clinical studies through the capturing of patient perspectives or impacts on recruitment and retention.

The FDA notes user fee revenue for RWE "shall be devoted solely to advancement of premarket uses." The FDA will annually publish a report containing examples of market authorization decisions made using RWE or real-world data (RWD) such as total number of submissions authorized from publicly available documentation. The FDA will also hire internal experts to support RWE and RWD submissions. Funding for the National Evaluation System for Health Technology may be used specifically to "transparently enhance premarket review process," with specific activities outlined in the draft commitments letter.

Digital Health

Underscoring the FDA's continued focus on digital health technologies and bolstering regulatory frameworks to keep pace with innovative artificial intelligence-enabled technologies, the FDA will hold regular, formal public engagement activities such as advisory committee or stakeholder meetings, as well as issue requests for information to inform a future regulatory approach. The FDA will also modernize reviews of digital health tools, allowing additional opportunities for industry engagement through pilot programs or "sandboxes" to demonstrate expectations for digital health technologies.

Harmonization with International Standards and International Collaboration

The FDA commits to enhance participation in and involvement with international regulatory bodies, with the CDRH to conduct outreach to other regulatory authorities at least 10 times per FY. The FDA will also share information on its framework with other regulatory authorities to enhance awareness on regulatory practices for medical devices, with an implementation plan issued for public comment by the end of FY 2028.

By the end of FY 2028, FDA will launch a pilot program for a device with the same intended use that is submitted to FDA and at least two other medical device regulatory authorities to support collaboration and ensure coordinated review. The FDA will review results from the pilot program and publish its findings no later than September 30, 2030, outlining successes and areas for improvement. The draft commitments letter does not indicate how two medical device regulatory authorities may be chosen if a device with the same intended use is submitted to the FDA and more than two other regulatory authorities, indicating additional clarification may be required to address such circumstances.

TAP Pilot to Feature Enhanced Interagency Coordination

Building on the experience of Total Product Life Cycle (TPLC) Advisory Program (TAP) under MDUFA V, the FDA proposes the transition TAP to cover all product areas, with voluntary enrollment targeted to eligible devices no later than October 1, 2027. The TAP Pilot, as of July 1, 2026, has 133 devices enrolled. Enrollment in the TAP Pilot aims to expedite patient access to innovative medical devices by offering streamlined communication between the FDA and developers to highlight a device's public health importance. The FDA began expanding enrollment requests acceptance across all Office of Health Technologies for certain designated devices.

In addition to expansion of the TAP Pilot, the FDA and Centers for Medicare & Medicaid Services will complete focused engagement and collaboration to align on evidence requirements "for technologies for which a new coverage determination would be beneficial" in reference to the Regulatory Alignment for Predictable and Immediate Device Coverage Pathway, which was announced by the FDA on April 23, 2026. The inclusion of this feature as part of the draft commitments letter indicates the FDA will pursue new efforts to reduce the time between product approval to Medicare coverage, which was previously pursued through regulatory efforts including Medicare Coverage of Innovative Technologies and Transitional Coverage for Emerging Technologies, through statute as opposed to guidance documents or rulemaking.

Looking Ahead

The substance of the commitments letter is subject to change until a final commitment letter is published and transmitted to Congress, and it could be subject to additional change as Congress drafts and advances the legislative framework for MDUFA. Regardless, stakeholders should review the draft commitments letter and assess whether policies and procedures could impact the research, development and submission of medical device products across all regulatory pathways. Comments are due by August 7, 2026.  Stakeholders should also consider whether to participate in the public meeting or provide written comments on the draft commitments letter. The deadline to request to participate during the public hearing is July 20, 2026, at 11:59 p.m. ET.

With the MDUFA reauthorization process moving forward, stakeholders should prepare for the release of additional commitment letters in the coming months outlining agreements between the FDA and other regulated industries, such as prescription drug, generic drug and biosimilars. Stakeholders with policy interest in any user fee program should also consider outreach to and advocacy with Congress to advance any potential policies not included in the draft commitments letter and inform the final MDUFA reauthorization package. Congress will view this as an opportunity to make changes to FDA policies and is not waiting on user fee action, with an educational hearing planned in the House Energy and Commerce Committee on July 15, 2026.

Holland & Knight's Healthcare & Life Sciences Team will continue to closely monitor any developments or changes. For questions, please reach out to the authors.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.