FDA and Medtech Industry Agree on MDUFA VI Draft Commitment Letter with Faster Pre-Submission Pathway and Enhanced Performance Goals
核心洞察
FDA and the medical device industry have reached agreement on the MDUFA VI draft commitment letter covering fiscal years 2028–2032, following months of negotiations that began in August 2025.
A new "Focused Follow-Up Pre-Submission" pathway will be created by the end of 2027, requiring FDA to respond within 45 days of receipt, faster than traditional pre-submission requests.
The agency commits to average total time to decision targets of 285 calendar days for PMAs and 128 calendar days for 510(k) notifications, decreasing to 112 days for 510(k)s by FY 2032.
The US Food and Drug Administration and the medical device industry have finalized draft commitment letter language for the Medical Device User Fee Amendments (MDUFA VI) program, setting the framework for device review funding and performance goals across fiscal years 2028 through 2032. The agreement, posted to FDA's website on Tuesday, follows months of negotiations that commenced after a public meeting in August 2025 and was jointly represented by the Medical Device Manufacturers Association (MDMA) (搜索) and AdvaMed (搜索) on behalf of industry.
"Advancing MDUFA VI is an important step toward preserving the seamless access to proven medtech patients deserve and the stability and predictability medtech innovators need to continue their critical work," said AdvaMed (搜索) CEO Scott Whitaker. "Patients rely on timely, expert FDA review of life-changing, life-saving medtech. This agreement helps provide FDA with the resources needed to support that mission, while giving medtech companies confidence to continue developing remarkable technologies for FDA review."
Following a public comment period and a hybrid public meeting scheduled for August 5, FDA will finalize the commitment letter and submit it to Congress. To avoid a lapse in the program, Congress must reauthorize MDUFA by September 30, 2027.
Focused Follow-Up Pre-Submission Pathway
A central innovation in the MDUFA VI agreement is the creation of a "Focused Follow-Up Pre-Submission" process, which FDA commits to implementing by the end of 2027. This new pathway will allow sponsors to receive regulatory responses faster than through the traditional pre-submission mechanism. Under the proposed framework, FDA would be required to respond to focused follow-up pre-submission requests within 45 days of receipt. Requests that do not meet specified requirements will be converted to traditional pre-submission requests.
FDA stated it will train staff and managers on the new review process and provide additional resources to stakeholders to clarify expectations for the focused follow-up pathway.
Major Deficiency Letter Reforms
Addressing longstanding industry complaints about insufficient detail in deficiency communications, FDA committed to ensuring that major deficiency letters are based on a complete review of the submission and will include all identified deficiencies. The draft letter specifies that deficiency letters will undergo supervisory review prior to issuance to ensure cited deficiencies are relevant to determinations of safety and effectiveness.
"Any subsequent deficiencies will be limited to issues raised by the information provided by the applicant in its response, unless FDA concludes that the initial deficiencies identified do not adequately address important new issues materially relevant to a determination of safety or effectiveness," the agency wrote. Such determinations will require appropriate management concurrence consistent with applicable guidance and standard operating procedures.
FDA further committed to conducting training on best practices for the consistent and appropriate use of review tools during deficiency development and review by September 30, 2028, and will survey recipients of deficiency letters to identify areas for improvement.
Time to Decision Targets
For premarket approval applications (PMAs), including original PMAs and panel track submissions, FDA is committing to an average total time to decision of 285 calendar days. For 510(k) notifications, the agency agreed to a decision within 128 calendar days on average at the start of MDUFA VI, with a commitment to reduce that figure to 112 calendar days by FY 2032.
The agreement also sets specific quantitative targets: FDA will issue an MDUFA decision within 180 FDA days for 90% of original PMA, product development protocol, panel-track supplement, and premarket report submissions. For submissions requiring advisory committee input, the commitment is an MDUFA decision within 320 FDA days. Additionally, 95% of 510(k) notifications will receive an MDUFA decision within 90 FDA days, and 90% of De Novo requests will receive a decision within 150 FDA days.
For Clinical Laboratory Improvement Amendments (CLIA) applications, FDA committed to issuing a decision for 90% of submissions within 90 calendar days.
Total Product Lifecycle Advisory Program (TAP)
The TAP pilot, which was a point of contention during MDUFA V negotiations, will be converted into a full-fledged program under the new agreement. The program enables engagement with external parties—including patient organizations, medical societies, and payers—to streamline the path to market for selected devices. FDA recently announced the pilot was open to all products covered under all its Offices of Health Technologies.
Under MDUFA VI, FDA committed to implementing specific metrics for the TAP program, including a teleconference with participants within 21 days for 90% of interaction requests, written feedback within 45 days for 90% of sprint discussion requests, and facilitation of engagement with the Center for Medicare and Medicaid Services (CMS) (搜索) within 21 days for 90% of requests where a new coverage determination would be beneficial.
Financial Transparency and Staffing
The draft letter includes financial transparency commitments, with FDA agreeing to publish a MDUFA financial plan by March 31, 2028, with annual updates thereafter. The agency will maintain a minimum of 8 weeks of operating reserves and may decrease registration fees if reserves exceed 15 weeks. If reserves fall below 8 weeks due to under-collections or factors beyond the agency's control, FDA may increase registration fees by an amount no greater than what would constitute 2 weeks of operating reserves per fiscal year until the minimum is restored.
On staffing, the agreement does not set specific hiring goals—unlike the previous MDUFA iteration—but does require twice-yearly reports on the number of CDRH employees per office and annual reports on hiring. FDA committed to hiring and retaining sufficient numbers of technical, scientific, and other program experts "consistent with what was agreed to under the MDUFA agreements." The agency also committed to publishing a Resource Capacity Planning and Management (RCPM) Implementation Plan on its website by March 31, 2029.
Consensus Standards and International Harmonization
FDA committed to enhancing the use of consensus standards, including further developing the Accreditation Scheme for Conformity Assessment, providing additional staff training on conformity assessments, and continuing support for the Third Party Review program. The agency will also launch a pilot program by the end of FY 2028 to coordinate product reviews with at least two other regulatory authorities for products with the same intended use submitted for regulatory review internationally, alongside continued engagement with organizations such as the International Medical Device Regulators Forum (IMDRF).
To ensure review consistency, FDA will work to improve review practices in at least one specific, high-impact topic each year, covering at least eight such topics over the five-year span of MDUFA VI. The medtech industry has agreed to provide a prioritized list of topics for the agency's consideration.