Makers of cardiovascular devices can navigate the dreaded “valley of death” for their unmarketed products by playing in an upcoming pilot program from the U.S. Food and Drug Administration (FDA) that will allow for earlier and more frequent engagement between developers and the agency’s Center for Devices and Radiological Health (CDRH). The goal is to help along innovative products by streamlining the device clearance process.
The voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot is “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,” device center Director Jeff Shuren said in Oct. 11 comments.
TAP was asked for by the FDA during talks for the recently passed Medical Device User Fee Amendments agreement, aka MDUFA V. Some industry stakeholders, however, had been lukewarm to TAP during those negotiations, questioning its cost and voicing other concerns.
Nevertheless, it’s full-steam ahead for TAP, with the FDA using a “phased-enrollment approach” for the pilot. For the pilot’s first phase, which begins on Jan. 1 and runs through the end of the current 2023 fiscal year (Sept. 30), the agency is looking for 15 makers of devices that fall under the purview of CDRH’s 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,” Shuren says.
The FDA says the pilot will build on lessons learned from its Breakthrough Devices Program and Early Feasibility Study Program, as well as the agency’s work with sponsors during the pre-Emergency Use Authorization process during the COVID-19 pandemic.
“Good things are coming out of the FDA from lessons learned during their COVID-19 pandemic response efforts,” MEDIcept Senior Regulatory Consultant Melissa Paffenroth said on Oct. 13. “If you are one of the lucky 15 cardiovascular devices included in the TAP pilot, you’ll have access to FDA advisors providing tailored advice, which will increase your submission quality and ability to generate evidence.
“Isn’t that what every manufacturer wants?”
CDRH chief Shuren adds that the pilot will include a “dedicated cadre of FDA advisors trained to provide proactive, dynamic, and strategic feedback and advice tailored to the specific needs of each developer” with a device enrolled in TAP. Further, the pilot “can help developers improve the quality of their submissions,” he says.
Shuren says TAP will focus first on “CDRH-designated Breakthrough Devices.” Beginning in 2026 the pilot will include products enrolled in the device center’s Safer Technologies Program, or STeP, which is modeled on, and is a complement to, the Breakthrough Devices Program.
“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,” Shuren says.
The agency will expand the pilot in FY 2024 by adding a second Office of Health Technology and 45 more medical devices. And additional OHTs and up to 65 other products will be added to the pilot 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 time frames,” Shuren says. “The FDA also will have an independent, third-party audit performed of the pilot.”
…Are you making a cardiovascular medical device and want to join the FDA’s new TAP pilot? Then let MEDIcept’s roster of experts help you. Our Regulatory Team is practiced at getting our clients Breakthrough Designations, so work with us today to apply for TAP. Check us out at www.medicept.com or drop us an email at email@example.com.