If you attended the FDA’s REdI Annual Conference (June 5-9, 2023) plenary session on User Fee Impact on FDA Programs, you may remember Dr. Jeff Shuren discussing the latest 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.”[1]
This means that FDA has created a specific program for manufacturers of medical devices that caters to increased and timelier communication with your regulatory review team for devices in the Breakthrough Designation pathway. 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? RQMIS can help you get to market faster through the TAP Pilot!
While the TAP Pilot only launched in Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices in January 2023, the FDA is planning a phased approach for enrollment efforts during 2023. The TAP Pilot will continue to expand its reach to other device types and review divisions throughout subsequent years to support greater numbers of devices (up to 60 devices through FY 2024, up to 125 devices enrolled through FY 2025, up to 225 through FY 2026 and up to 325 through FY 2027).
Please reach out to RQMIS for more details to help navigate TAP Pilot enrollment and be one of the first manufacturers to take advantage of FDA’s early and strategic communications program.
[1] “Total Product Life Cycle Advisory Program (TAP).” U.S. Food and Drug Administration, 2 Mar. 2023, www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap#enrollment.
