CDRH’s Plan to De-risk the Medical Device Valley of Death

As was introduced in our recent blog post summarizing the 2022 MedTech conference (here), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot (see announcement attributed to CDRH director Jeff Shuren, M.D., J.D. (here), Federal Register notice (here) and the Program Website (here)).  The TAP Pilot is intended to “de-risk the medical device valley of death,” the metaphorical place where innovative technologies die while trying to reach the market. U.S. Food & Drug Admin., CDRH Launches the Total Product Life Cycle Advisory Program Pilot (Oct. 11, 2022) [hereinafter “Announcement”]. One cause of death in this “valley” is related to the need to understand and meet regulator expectations.

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” U.S. Food & Drug Admin., Total Product Life Cycle Advisory Program (TAP) (Oct. 11, 2022) [hereinafter “Program Website”].

The TAP Pilot will build on the CDRH’s experience engaging with developers during the COVID-19 pandemic through the pre-EUA pathway, as well as the Agency’s experience with the Breakthrough Devices and Early Feasibility Study Programs. To implement the Tap Pilot, CDRH plans to build dedicated teams of advisors trained to provide feedback and advice tailored to the specific needs of each developer.  See Announcement.

A key goal of the TAP Pilot is to reduce time from concept to commercialization through improved engagement with developers and increased predictability of CDRH’s review.  Id.  Specifically, CDRH intends to engage with participants in a timely manner to facilitate improved decision-making during device development, including earlier identification and mitigation of risk and better alignment of expectations related to evidence generation.  See Program Website.

CDRH has established the following performance goals to achieve these objectives of improved engagement, which will be tracked and reported during the pilot, beginning in FY 2024.

• CDRH will engage in a teleconference with the participant on requested topic(s) pertaining to the TAP device within 14 days of the request for 90% of requests for interaction.
• CDRH will provide written feedback on requested biocompatibility and sterility topics(s) pertaining to the TAP device within 21 days of the request for 90% of such requests for written feedback.
• CDRH will provide written feedback on requested topic(s) pertaining to the TAP device other than biocompatibility and sterility within 40 days of the request for 90% of requests for written feedback.

Id.

CDRH plans to take a phased approach to implement the TAP Pilot throughout the duration of MDUFA V (FY 2023 – FY 2027).  The first phase, identified as the TAP Pilot Soft Launch, will begin January 1, 2023 and run through FDA’s FY 2023.  CDRH plans to enroll 15 devices evaluated by the Office of Health Technology 2 (OHT2):  Office of Cardiovascular Devices.  In the remaining years of the pilot, CDRH will begin tracking performance, will add additional offices, and increase the number of devices in the pilot.  Id.  The TAP Pilot will first focus on CDRH-designated breakthrough devices.  Devices in the Safer Technologies Program (STeP) will be included in FY 2026.  See Announcement.  An independent third party (or parties) will conduct assessments of the TAP Pilot beginning in FY 2024.  See Program Website.

A device is eligible for inclusion in the soft launch of the TAP Pilot if it is in early development and has received Breakthrough Device designation, but the participant has not yet submitted a Q-Submission request after receiving Breakthrough status.  A participant may enroll only one device per fiscal year.  Devices regulated by the Center for Biologics Evaluation and Research (CBER) and combination products are outside the scope of the TAP Pilot.  Id.

All in all, we think the TAP Pilot has the potential to be a valuable program and we applaud the Agency for including performance metrics and third-party assessment to evaluate its effectiveness.  Although the program is not intended to reduce evidentiary burdens for innovative devices, earlier communication of Agency expectations foreseeably could help some developers avoid the valley of death for their products.  There are many innovative devices, however, that do not meet the criteria for Breakthrough or STeP designation that find themselves in the valley of death, so we hope the TAP Pilot, if successful, will be broadened to include more types of devices, as well as devices regulated by CBER and combination products.