CDRH Launches Pilot Program To Reduce Device Approval Times

By MedTech Intelligence Staff
October 12, 2022


• Categories: 05-Quality/Regulatory, Market Access, Regulatory

The FDA Center for Devices and Radiological Health (CDRH) 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,” said Jeff Shuren, M.D., J.D., director of the FDA CDRH.

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 program is to improve various aspects of medical device development and to increase the predictability and reduce the time from concept to commercialization, said Dr. Shuren.

There will be a phased enrollment throughout the duration of MDUFA V. The first phase is the TAP Pilot Soft Launch, which will begin on January 1, 2023 and run through the first year. During the 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,” said Dr. Shuren.

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 2024, followed by additional OHTs and up to 65 additional devices in 2025. In 2026, 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.

Performance goals that the TAP Pilot will track each year include the goal of responding to 90% of TAP participants’ requests for interactions and feedback within specified timeframes, which the CDRH notes will require additional resources. In preparation, the CDRH has begun recruiting experts at both leadership and staffing levels to manage the program.

“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,” said Dr. Shuren. “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.”