Stakeholders Generally Back Draft MDUFA VI Letter Despite Concerns

Medical technology organizations and regulatory experts are broadly supporting the proposed Medical Device User Fee Amendments VI agreement, while continuing to raise concerns about FDA staffing capacity, hiring accountability, and safeguards governing the use of real-world evidence. 

The draft commitment letter establishes FDA’s medical device review goals and procedures for fiscal years 2028 through 2032. The current MDUFA V authorization expires September 30, 2027, and the final recommendations must be transmitted to Congress by January 15, 2027. Following an August 5 public meeting, FDA will consider stakeholder comments before finalizing the agreement. The draft letter and supporting materials are available on the FDA’s MDUFA VI webpage. 

AdvaMed expressed strong support for the proposal at the public meeting. Zach Rothstein, the association’s executive vice president of Digital and Diagnostics Technologies, said the agreement builds on successful programs, makes practical improvements, and prepares FDA for emerging technologies. The association emphasized that a predictable and adequately funded review program is essential to patient access and continued U.S. leadership in medical technology.  

The proposal largely retains existing review-time goals while adding targeted process improvements. These include a new Focused Follow-Up Pre-Submission pathway with a 45-day response target, structured introductory meetings for de novo requests, expanded staff training on deficiency letters, further development of the Total Product Life Cycle Advisory Program, digital-health investments, and an international regulatory harmonization pilot. 

Industry experts interviewed by Regulatory Focus welcomed the faster pre-submission option and stronger expectations for complete, clearly explained deficiency letters. However, they cautioned that FDA remains resource-constrained and has lost experienced personnel and institutional knowledge. One expert characterized the agency as doing strong work with limited resources but warned that operational improvements alone cannot fully compensate for inadequate capacity.  

Staffing remains one of the most significant unresolved concerns. Unlike MDUFA V, the draft agreement does not include specific numerical hiring targets. Instead, FDA would report twice annually on Center for Devices and Radiological Health staffing by office and annually on hiring activity. MedTech Dive reported that industry and patient groups had sought greater staffing transparency following workforce reductions and growing reviewer workloads. The publication noted that the agreement provides more visibility but stops short of guaranteeing that FDA will add enough reviewers and technical experts to meet future demand.  

Stakeholders have also focused on the proposed investment in real-world data and real-world evidence. MDUFA VI would fund RWE work through the National Evaluation System for Health Technology, support FDA reviewer training, hire internal RWE experts, and require annual reporting on authorization decisions that relied on RWD or RWE. The letter specifies that user-fee revenue allocated to these activities must be devoted solely to advancing premarket uses. 

Nevertheless, industry has requested more detail about the full-time employees assigned to RWE initiatives, the data sources FDA expects to use, and the governance of those activities. As RAPS reported during the negotiations, manufacturers supported continued development of RWE and the NEST Mark but sought assurances that user fees would not be redirected toward broader, non-premarket activities. 

Patient and consumer advocates have raised a different concern: RWE should complement - not replace - well-designed clinical trials when evaluating device safety and effectiveness. They have called for greater transparency regarding data quality, methodology, potential bias, and the evidentiary role RWE plays in individual regulatory decisions. 

For Michigan medical device, diagnostic, digital-health, and combination-product companies, MDUFA VI promises more structured FDA interaction and potentially greater review predictability. Its success, however, will depend on whether the agency has sufficient experienced personnel to implement the commitments consistently and whether its RWE initiatives maintain rigorous, transparent scientific standards. 

MichBio will continue monitoring the reauthorization process as FDA finalizes its recommendations and Congress begins considering the legislation needed to sustain the medical device user-fee program.