MDUFA VI: FDA, industry make headway in reauthorization negotiations

The US Food and Drug Administration (FDA) and the medtech industry have reached agreement on several key areas as they negotiate the next iteration of the Medical Device User Fee Amendments (MDUFA VI) program. Among the areas of agreement is using the next round of fees to fund upgrades to the agency's IT systems and changes to its de novo and pre-submission programs.

The MDUFA negotiations between the FDA and the medtech industry have been ramping up over the past month, as both sides reached agreement on several issues during their 18 February meeting, the most recent meeting minutes published. Starting off the meeting, the industry, which is represented by AdvaMed and the Medical Device Manufacturers Association (MDMA), said it supported FDA's proposals on enhancing its Information Technology (IT) tools, de novo pathway, and pre-submissions process.

FDA proposed upgrading its existing IT infrastructure, arguing that it would be more efficient and improve the customer service experience. More specifically, the agency said it wants to further automate submission processing and enhance portal functionality. The agency noted that upgrading the IT infrastructure would continue to incur maintenance costs beyond 2032, when the next MDUFA program ends.

The agency had previously reported that both sides had developed ideas to update the de novo and pre-submission programs as part of internal deliberations and offline discussions. The meeting minutes noted that both sides have reached an agreement on several proposals to update the programs but did not provide details on those proposals.

FDA and industry also reached an agreement on carryover funds between the operating reserve floor and ceiling, prioritizing funneling carryover funds to specific areas to support review of device applications, and retaining a mechanism to offset registration fees for the following fiscal year if and when the carryover funds exceed a specific limit.

"FDA agreed to Industry's request to discuss the status of the carryover balance and potential allocation of funds at two quarterly meetings," said FDA. "FDA and Industry agreed on opportunity to elevate certain allocation decisions to the Agency for reconsideration within a specific notification window, subsequent reporting on final allocation of carryover funding, and the preservation of existing process checks for allocating carryover funding.

"FDA and Industry discussed the operating reserve floor and ceiling, with the parties still not aligned on the appropriate number of weeks," the agency added.

FDA proposed including a flat fee for pre-submissions in the fee structure model. Companies would be charged only for the original pre-submission and not for supplements, follow-ups, or informational Q-submissions. Furthermore, the agency said the fee would be credited to the costs of the subsequent marketing submission if and when the company files a premarket submission.

Another key part of the ongoing discussions is about how to achieve more consistency in product reviews. During the 18 February meeting, regulators proposed changes that they argue will build on the improvements made in MDUFA V.

"FDA proposed the commitment letter state that FDA will make improvements to facilitate appropriately consistent and effective review in one specific, high-impact topic area per year and provide industry with an update on these improvements once per year," said the meeting minutes. "Industry expressed support for the proposal and had suggestions for minor revisions.

"After FDA shared the FTEs and operating dollars needed for the proposal, Industry asked if additional resources would allow FDA to evaluate two specific topic areas per year instead of one," the minutes added. "FDA indicated they would take that back.

FDA said that both sides agreed to the proposal and that they will no longer need to produce a report on MDUFA return-on-investment (ROI) in MDUFA VI.

An important topic during the past few meetings was how to move forward with the Total Product Lifecycle Advisory Program (TAP). FDA proposed a TAP 2.0 program that would entail enhancing the breakthrough review experience and more focused engagement with the Center for Medicare and Medicaid Services (CMS). The agency also proposed benefits for non-TAP devices, changing its enrollment criteria to allow more US manufacturers to participate, updating metrics, and reducing operating expenses.

TAP 2.0 was also discussed during the 11 February meeting, during which the industry asked for further clarity about the continuation of the proposed program, including current staffing levels, and about the roles and responsibilities of the TAP advisors. Industry also expressed opposition to the cost of the program and asked FDA for more specifics about what the costs would cover.

Overall, the meeting minutes state that FDA and industry have agreed to proposals for MDUFA VI that address patient science, digital health, the third party 510(k) review program, continuous improvements to address deficiencies, international harmonization, 510(k) total time to decision, consensus standards, de novo, pre-submissions, Resource Capacity Planning and Management (RCPM) capability development that doesn’t include a capacity planning adjustor (CPA), and upgrades to FDA’s IT tools.

FDA

MDUFA VI: FDA, industry make headway in reauthorization negotiations

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