A common misconception in the Medical Device industry is that FDA is impossible to interact with and that they have no interest in working with Industry. However, the newly soft launched Total Product Life Cycle (TPLC) Advisory Program (TAP) program is proving this misconception wrong.
What is TAP?
On January 1, 2023, FDA started accepting applications for the TAP Pilot Soft Launch. The TAP pilot program is part of the Medical Device User Fee Amendments for fiscal years 2023-2027 (MDUFA V). The objective of this initiative between FDA and Industry is to help encourage more rapid development and widespread patient access to medical devices of public health importance. The goal of TAP is to “help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors” by reducing the amount of communication time for documentation. The plan is to demonstrate the feasibility and benefits of process improvements to FDA’s early interactions and facilitation of interactions between participants and stakeholders. Through the program, FDA intends to provide innovative devices of public health importance with strategic engagement, largely focused on improving communication timeframes and frequency (premarket, device development, and review) between FDA, participants, and stakeholders. The long-term goal of the TAP program is to ensure the sustained success of the Breakthrough Devices Program. The Breakthrough Devices Program is a voluntary program intended to maintain FDA’s rigorous standards of safety and efficacy while improving response times and access to medical and combination devices for the treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
A Phased Approach to TAP Launch
A phased-enrollment approach is being used for the program which started with the Soft Launch of 15 devices from the Offices of Health Technology 2 (OHT2) and Cardiovascular Devices. The initial devices were selected based on factors including historical number of granted Breakthrough designations from OHT2, workload, staffing levels, and experience with review paradigms involving rapid interactions. As the program matures, it will expand to enroll more devices (up to 325 total by 2027) while supporting those already in the program. FDA’s most recent update on July 31, 2023, announced that 5 more devices had been enrolled in the TAP Pilot and beginning on October 1, 2023, the Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).
To be considered for the program, devices must be early in the development process, have been granted Breakthrough Device designation but have not submitted for Pre-Submission. Applicants will be contacted by FDA if they are accepted, rejected (with reasons) or if enrollment is at capacity. Participants can only have 1 device enrolled in the program per year. Restrictions for this program include devices regulated by the Center for Biologics Evaluation and Research (CBER) and combination products.
To achieve the intended goal of TAP, FDA will implement and track performance metrics beginning in 2024. These metrics include teleconference on requested topics (within 14 days for up to 90% of these requests), written feedback on requested biocompatibility and sterility topics (within 21 days of the request for 90% of these requests) and written feedback on all other requested topics (within 40 days of these request for 90% of these requests). FDA will also assess the Pilot using an independent third-party assessment including a participant survey and quantitative and qualitative success metrics.
This initiative and its commitment to promoting better FDA interaction with medical device developers proves the Agency’s commitment to becoming more reachable and breaking the stigma that FDA isn’t accessible.
To discuss how this initiative impacts your organization, contact firstname.lastname@example.org to schedule an Analyst Inquiry.
The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this report is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This report is not intended to endorse any company or product and should not be attributed as such.