MDUFA VI: Draft commitment letter details enhancements, performance goals
The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical Device User Fee Amendments (MDUFA VI) program for the next five fiscal years.
The agreement is the result of months of negotiation between FDA and industry that kicked off following a public meeting on the sixth iteration of the device user fee program in August 2025. Under the draft commitment letter posted to FDA’s website on Tuesday, the agency agreed a new “focused follow-up” pre-submission pathway for faster responses, enhanced timeframes for premarket submissions, and to convert the total product lifecycle advisory program (TAP) pilot into a full-fledged program.
"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," FDA wrote. "FDA and applicants share the responsibility for achieving this objective for the average Total Time to Decision, while maintaining standards for safety and effectiveness.”
The Medical Device Manufacturers Association (MDMA) and AdvaMed represented the medical device industry during the negotiation process.
"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 CEO Scott Whitaker after the letter was published. "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," he added.
Following a public comment period, FDA will finalize the commitment letter and send it to Congress. To avoid a lapse in the program, Congress must reauthorize MDUFA by 30 September 2027.
Focused pre-submission pathway
A key update to the program would be to create a focused follow-up pre-submission process by the end of 2027, allowing sponsors to receive responses faster than with a traditional pre-submission request. While FDA will continue to operate its traditional pre-submission program, which allows sponsors to engage regulators early as they prepare to submit a premarket submission, the new pathway would require regulators to respond to companies even earlier, within 45 days of receipt. If focused follow-up pre-submission requests don't meet certain requirements, they will be converted to a traditional pre-submission request.
FDA said it will train its staff and managers on the new pre-submission review process and provide additional resources to stakeholders to clarify expectations for the focused follow-up pre-submission process.
Major deficiency letters
Industry has long complained of a lack of detail in major deficiency letters. The agency said it would ensure that major deficiency letters are based on a complete review of the submission and will include all the deficiencies it has found.
"Deficiency letters will undergo supervisory review prior to issuance to ensure the deficiencies cited are relevant to a determination of safety and effectiveness," said the letter. "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.
"Such a determination will be supported by the appropriate management concurrence consistent with applicable guidance and SOPs," the agency added. "Issues related to post-approval studies, if applicable, and revisions to draft labeling will typically be addressed through interactive review once major deficiencies have been adequately addressed."
Furthermore, FDA said it will continue to work on improving its deficiency communication and training staff and managers on applicable guidances and best practices. Part of its efforts to improve its deficiency communication would include conducting such training by 30 September 2028, covering best practices for the consistent and appropriate use of review tools during the development and review of deficiencies. The agency also said it would survey recipients of deficiency letters to learn how it can improve the process.
Time to decision
For PMAs, including original PMAs and panel track submissions, FDA is committing to provide a decision within 285 calendar days on average. For 510(k) notifications, the agency agreed to provide a decision on average within 128 calendar days at the start of MDUFA VI and to work to reduce that to 112 calendar days by FY 2032.
"In the event that FDA’s annual appropriations for the devices and radiological health program are re-baselined under the statutory appropriations trigger process, the Agency will continue to apply user fee resources on MDUFA process activities, continue to meet the MDUFA spending condition described in section 738(h)(2) of the FD&C Act, and will continue to strive to meet all commitments under this agreement," the agency stated.
FDA agreed to issue a MDUFA decision within 180 FDA days for 90% of original PMA, product development protocol, panel-track supplement, and premarket report submissions. It is also committed to issuing an MDUFA decision within 320 FDA days for submissions that require an advisory committee's input. Furthermore, the agency said it would issue a MDUFA decision within 30 days of the committee's recommendation, depending on its resources, if it does not conflict with quantitative review timelines and statutory obligations.
FDA also agreed to issue a MDUFA decision within 150 FDA Days for 90% of De Novo requests. If it issues a not grantable letter for the de novo request, the agency said it would give a final determination to decline or grant the submission within 75 calendar days of receiving a response to the not grantable letter, but not later than 90 calendar days.
95% of 510K(k) notifications will receive a MDUFA decision from FDA within 90 FDA days if the deal commitment letter is approved as is. The agency also said it would give a decision to 90% of Clinical Laboratory Improvement Amendments (CLIA) applications within 90 calendar days.
Financial transparency & hiring
The letter includes financial transparency and hiring commitments from FDA, including a commitment to publish a MDUFA financial plan by 31 March 2028 and update the plan every year thereafter. The updates will include changes in personnel compensation and benefit costs, an accounting of appropriated user fee funds included in the operating reserves at the end of each fiscal year, and the carryover balance of user fee funds.
"MDUFA VI will provide for FDA to maintain a minimum of 8 weeks of operating reserves and decrease registration fees in the following fiscal year if operating reserves exceed 15 weeks, as provided for in statute," states the letter. "If operating reserves fall below 8 weeks, FDA may increase registration fees in the subsequent fiscal year by an amount no greater than what would constitute 2 weeks of operating reserves, per fiscal year, until the minimum is restored.
"This adjustment will only be applied to registration fees if operating reserves fall below the minimum due to under-collections or other factors beyond the Agency’s control," the letter added. "User fee funds in the carryover balance that are considered unappropriated or unearned are not included in the operating reserves."
FDA emphasized that it would continue to improve its reviewer training program and develop its resource capacity planning and management (RCPM) capabilities. The agency committed to publishing a MDUFA RCPM Implementation Plan on its website by 31 March 2029 that will include descriptions and development milestones for staffing, organization, concept of operations, data development and analytics, system integration, and reporting.
As part of its efforts to ensure review consistency, FDA said it would work to improve its review practices in at least one specific, high-impact topic each year and cover at least eight such topics over the five-year span of the upcoming MDUFA program. For its part, the medtech industry has agreed to provide the agency with a prioritized list of such topics for consideration.
Consensus standards & harmonization
FDA has committed to enhancing the use of consensus standards, including further developing the Accreditation Scheme for Conformity Assessment, providing additional training to staff on using conformity assessments, and further developing regulatory tools and standards. It also said it would continue to support the Third Party Review program and take actions to engage stakeholders, including patients, healthcare providers, industry, and others, to incorporate diverse perspectives into its regulatory decision-making.
The draft commitment letter addresses FDA's ongoing work to achieve international harmonization with global regulators, including funding and supporting future international engagements with organizations such as the International Medical Device Regulators Forum (IMDRF). The agency also said it would launch a pilot program by the end of FY 2028 to review products with the same intended use that have been submitted for regulatory review to at least two other regulatory authorities, to allow them to coordinate the product review.
TAP
The TAP pilot was a controversial factor in the previous MDUFA negotiations. The pilot enables engagement with external parties, including patient organizations, medical societies, and payers with the goal of streamlining the path to market for selected devices. While the medtech industry initially opposed the program during the MDUFA V negotiations, it eventually acquiesced to a pilot to evaluate its viability, which FDA recently announced was open to all products covered under all its Offices of Health Technologies.
Under the MDUFA VI commitment letter, FDA said it would use what it learned from the pilot and feedback from the medtech industry and agency staff to develop a full-fledged TAP program. The agency said it would also implement certain metrics for the TAP program.
"FDA will engage in a teleconference with the participant on requested topic(s) pertaining to the TAP device within 21 days of the request for 90% of requests for interaction," said FDA. "FDA will provide written feedback on requested topic(s) pertaining to the TAP device within 45 days of the request for 90% of requests for sprint discussions.
"For TAP technologies for which a new coverage determination would be beneficial, FDA will facilitate engagement with [the Center for Medicare and Medicaid Services (CMS)] within 21 days of when the engagement topic is finalized for 90% of requests for non-FDA party engagement," the agency added.
As with past MDUFA programs, FDA committed to providing performance reports to the medtech industry on the progress it has made in terms of meeting goals laid out in the commitment letter. The agency has also scheduled a public hybrid meeting on 5 August to discuss the commitment letter and take public feedback.
