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FDA Launches Pilot Program to “De-risk the Medical Device Valley of Death”

by | Oct 12, 2022 | News, Open Content

The CDRH Total Product Life Cycle Advisory Program Pilot aims to improve the FDA authorization process for medical devices.

On Oct. 11, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), announced in a statement that the center had launched its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.

The program, which is part of the Medical Device User Fee Amendment (MDUFA) V Agreement that was passed by Congress at the end of September, aims to foster faster development of “high-quality, safe, effective, and innovative medical devices first in the world that are critical to public health,” Shuren wrote. According to Shuren, the TAP program will meet that key objective through:

  • Improved communication and engagement between CDRH and the medical device industry, achieved through “earlier and more frequent interactions with CDRH;”
  • “More strategic input from stakeholders;” and
  • “Proactive, strategic advice from CDRH”

More specifically, the program looks to set up a group of FDA advisors trained to meet the “specific needs of each developer who has a device in the program,” Shuren stated. This group aims to ensure that problems are identified earlier in the FDA authorization process, so those issues can be fixed quickly and delays reduced. Input from patients and healthcare providers is another main component of the program, helping to ensure device developers are meeting their clients’ needs.

To ensure goals are being met, Shuren says the pilot will track a number of key metrics and will undergo “an independent, third-party audit.”

The CDRH Plan for Implementing the TAP Pilot

According to the Oct. 11 statement, the CDRH will roll out the TAP program in phases over the next five years. The first phase, the TAP Pilot Soft Launch, will run during fiscal year (FY) 2023, starting on Jan. 1. This phase will involve the enrollment of 15 devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices, Shuren said.

He adds the program “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” during MDUFA V.

After phase one of the program, the CDRH says the next steps involve:

  • FY 2024: Bring in a second OHT and enroll as many as 45 additional devices
  • FY 2025: Include additional OHTs and enroll a maximum of 65 more devices
  • FY 2026: Add Safer Technologies Program (STeP) devices to the program

The program will draw on the many lessons learned from responding to the COVID-19 pandemic, as well as from the agency’s Early Feasibility Study and Breakthrough Devices Programs, Shuren said.

“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,” he stated. “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.”