Total Product Life Cycle Advisory Program (TAP) Pilot

Understanding the TAP Pilot: Total Product Life Cycle Management
About this Event

Date: Nov 1,2024

Time: 1 PM -2:30 PM ET

Duration:90 Mins

Description

The session is focused on User Fee Impact on FDA Programs which highlights CDRH initiatives to improve the Agency’s ability to be agile in an ever-changing device market. As part of the Agency’s efforts, CDRH has launched the Total Product Life Cycle Advisory Program (TAP) Pilot to “ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors.
Areas Covered:

The FDA has already enrolled four devices in the TAP Pilot. Are you looking to submit your device for Breakthrough Designation? Have you been granted Breakthrough status but are uncertain where to go next? The session will cover and help you to understand the device market faster through the TAP Pilot!
Why Should One Attend the Session and Who Will Benefit:

By attending this session, attendees will benefit how to navigate the landscape of complex TAP Pilot enrollment and be one of the first manufacturers to take advantage of FDA’s early and strategic communications program to get market authorization.