The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health
Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced it is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid development of high-quality, safe, effective, and innovative medical devices first in the world that are critical to public health.
The TAP Pilot is a new component of the Medical Device User Fee Amendment (MDUFA) V Agreement, which was signed into law on September 30, 2022, and reauthorized for five years. A key goal of the TAP Pilot is to improve various aspects of medical device development and to increase the predictability and reduce the time from concept to commercialization, in part, by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
To implement the TAP Pilot, CDRH intends to take a phased-enrollment approach throughout the duration of MDUFA V. The first phase is the TAP Pilot Soft Launch, which will be conducted during FY 2023 and begin on January 1, 2023. During the TAP Pilot Soft Launch phase, CDRH intends to enroll up to 15 devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices. OHT2 was chosen based on multiple factors, including the office’s historical number of granted Breakthrough Device designations, workload, staffing levels, and experience with programs involving rapid interactions, such as Early Feasibility Studies.
The TAP Pilot will build upon the lessons learned from the Breakthrough Devices and Early Feasibility Study Programs, as well as our experience engaging with sponsors during the pre-EUA process as part of our COVID-19 pandemic response efforts. Throughout the COVID-19 pandemic, we have seen the transformative impact of near and real-time interactions between developers and CDRH experts getting devices developed, evaluated, and authorized quickly. However, that level of engagement requires specific and dedicated resources. CDRH has already begun recruiting the additional expertise needed at both the leadership and staffing levels to ensure the successful launch of the Pilot.
The TAP Pilot will include establishing a dedicated cadre of FDA advisors trained to provide proactive, dynamic, and strategic feedback and advice tailored to the specific needs of each developer who has a device in the program. TAP Pilot feedback can help developers improve the quality of their submissions, including a better understanding of the FDA’s expectations regarding generating evidence to support submissions. By providing medical device developers with earlier and more frequent interactions with the FDA’s advisors and review teams, it will better enable prompt identification of device issues that might delay the FDA’s authorization, so those issues can be addressed earlier in the development process and improve the chances of faster authorization.
In addition, by facilitating coordination of earlier, solutions-oriented input from patients, health care providers, and health insurers and other payers, the TAP Pilot can help developers better address patient needs and anticipate reimbursement and market adoption considerations. That input can be of significant value throughout device design and development, during clinical trials, and even when rolling out devices post-authorization.
Over the course of MDUFA V, the TAP Pilot will first focus on CDRH-designated breakthrough devices, which provide for safer, more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. In FY2026, CDRH intends to include Safer Technologies Program (STeP) devices in the TAP Pilot, which are safer alternatives to currently available treatments or diagnostics for other conditions. TAP is intended to build on the FDA’s and industry’s experiences with those programs, as well as help improve those programs and ensure their success. At this time, devices regulated by the Center for Biologics and Evaluation (CBER) and combination products are outside the scope of the TAP pilot.
Following the Soft Launch, the FDA intends to expand the TAP Pilot to include a second OHT and enroll up to 45 additional devices in FY 2024, followed by additional OHTs and up to 65 additional devices in FY 2025. There are a number of performance goals that the TAP Pilot will track each year, including the goal of responding to 90% of TAP participants’ requests for interactions and feedback within specified timeframes. The FDA also will have an independent, third-party audit performed of the Pilot.