Medical device industry expresses concern on direction of FDA’s TAP 2.0 program

The medical device industry has expressed concerns about the US Food and Drug Administration’s revised proposals for resource allocations and enrollment for the Total Product Lifecycle (TAP) program 2.0 program as part of the negotiations for the Medical Device User Fee Amendments VI (MDUFA). Industry also supported extending benefits beyond enrolled products.

The sixth iteration of MDUFA will cover fiscal years 2028 to 2032. These proposals were mentioned in the meeting minutes from the MDUFA discussions held with industry representatives on 4 February. The current user fee program for devices will expire on 30 September 2027.

The meeting included representatives for FDA’s Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), FDA’s Office of the Chief Counsel (OCC), the Office of Compliance (OC), and consultants to FDA.

Industry representatives at the meeting included the Advanced Medical Technology Association (AdvaMed), GE Healthcare, Medtronic, the Medical Device Manufacturers Association, Boston Scientific, Siemens Healthineers, and Cook Medical.

During the February meeting, FDA began by recognizing that the agency and the industry still held differing views on important aspects of TAP 2.0. This recognition follows a December meeting in which the FDA presented its proposal to revise the program.

According to the minutes from the December meeting, “For MDUFA VI, FDA proposed to continue TAP 2.0 as a significantly smaller-scale, permanent program, which reflects a narrowed scope and incorporates lessons learned from the TAP pilot.”

In addition, the criteria for TAP enrollment could be updated to focus on a more “impactful” group of breakthrough technologies, specifically targeting companies that can benefit from rapid regulatory feedback, according to the minutes.

According to the minutes from the February discussions, industry representatives provided initial feedback on the revised proposal and raised additional questions about the structure, eligibility, and funding of the TAP program.

Additionally, industry suggested that FDA should ensure that the expertise and benefits of the program extend beyond the subset of enrolled TAP products.

FDA announced the establishment of its TAP pilot in January 2023, which was negotiated under the MDUFA V, that would allow sponsors to get feedback from external stakeholders on how to bring products to markets. (RELATED: FDA opens TAP, Regulatory Focus 3 January 2023)

FDA announced an expansion of the program, known as TAP 2 in July 2024 which would include devices reviewed in the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) in the fall of 2024, followed by the Office of Orthopedic Devices (OHT6) in 2025.

The industry also proposed updates to the MDUFA quarterly reporting process to include staffing levels by office. They also suggested refining the language in the commitment letter to specify the actions taken by CDRH to evaluate performance variability. Additionally, they recommended implementing training activities aimed at reducing this variability and reassessing performance at least twice a year. FDA said it would discuss these proposals internally and would provide feedback at the next meeting.

The agency provided an updated financial overview for MDUFA VI, focusing on changes to the fee structure that align with America First principles. FDA discussed fee estimates and modeling assumptions of the proposed fee differential between foreign and US establishments. In response to questions from Industry, FDA said it would provide further granularity on the economic modeling and will clarify details on the underlying economic analyses. Industry expressed general support for the revisions to the fee structure.

Meeting minutes

Medical device industry expresses concern on direction of FDA’s TAP 2.0 program

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