Description: FDA’s Center for Devices and Radiological Health (CDRH) introduced the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in late 2022 as a program intended to de-risk the medical device valley of death, the metaphorical place where innovative technologies die while trying to reach the market. To be eligible for the TAP Pilot, a device must be in early development, have received Breakthrough Device designation, and not had a Q-Submission request after receiving Breakthrough status. 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. 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. The program also provides participants with opportunities for strategic engagement with non-FDA stakeholders.
This session will provide an overview of the TAP Pilot, options for participant interactions with FDA, and a discussion of real-world experience and benefits of the program.
Learning Objectives:
Upon completion, participant will be able to describe the goals of the TAP Pilot.
Upon completion, participant will be able to determine if a device is eligible for the TAP Pilot and understand how to submit for TAP enrollment.
Upon completion, participant will be able to describe the processes and benefits of the TAP Pilot.
