Following a period of intensive negotiations between the U.S. Food and Drug Administration (FDA) and representatives from the medical device sector, a draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) program has been finalized. This MDUFA VI agreement outlines the regulatory framework for the next five fiscal years, focusing on accelerating the review of medical technologies and fostering a more predictable path for innovators. The draft, released on July 7, establishes new “focused follow-up” programs for pre-submissions, aimed at providing faster response times for manufacturers seeking guidance. The Medical Device Manufacturers Association and AdvaMed represented industry interests throughout the process. Scott Whitaker, president and CEO of AdvaMed, stated, “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.” He further added, “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.”
Accelerating Pre-Submission and Quality Communication
The newly proposed framework introduces an expedited consultation pathway that promises manufacturer feedback within 45 days of a request, a notable improvement over current timelines. To qualify for this accelerated route, applicants must adhere to specific eligibility criteria; otherwise, submissions will revert to the standard track. The agency plans to initiate staff training and issue formal guidance on these requirements by September 2028. Additionally, the FDA has pledged to address long-standing industry feedback regarding the clarity of rejection notices by issuing comprehensive deficiency letters. These communications will consolidate all identified issues into a single document and undergo management review prior to issuance to ensure citations are directly linked to safety and efficacy standards. Subsequent deficiency notices will generally be limited to concerns arising from the applicant’s responses, unless significant safety issues are discovered.
Standardized Review Timelines and Resource Management
Under the MDUFA VI agreement, the agency has set specific performance goals for various submission types. For Premarket Approval (PMA) applications, the FDA intends to reach a decision within an average of 285 calendar days. For 510(k) clearances, the initial target is 128 calendar days, with a goal to reduce this further to 112 days by fiscal year 2032. The draft letter notes, “FDA and representatives of the industry agree that the process improvements outlined in this letter, when implemented by all parties as intended, should achieve the average Total Time to Decision targets for premarket approval applications (PMAs) and premarket notification (510(k)) submissions, provided that the total funding of the device review program adheres to the assumptions underlying this agreement.” The agency also emphasizes a shared burden of success: “FDA and applicants share the responsibility for achieving this objective for the average Total Time to Decision, while maintaining standards for safety and effectiveness.”
Furthermore, the agency aims to deliver determinations on 90% of De Novo classification requests within 150 FDA days and 95% of 510(k) notifications within 90 FDA days. To ensure consistent performance, the agency will publish a Resource Capacity Planning and Management Implementation Plan by March 2029, detailing staffing and organizational strategies. International regulatory cooperation also remains a priority, with plans to launch a pilot program by the end of fiscal year 2028 that enables coordinated reviews with at least two other regulatory bodies through the International Medical Device Regulators Forum (IMDRF). Following a public meeting scheduled for August 5, the final commitment letter is expected to be sent to Congress by January 15, 2027, with enactment required by September 30, 2027.
