On Tuesday, the U.S. Food and Drug Administration (FDA) announced it is launching the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot within the Center for Devices and Radiological Health (CDRH).
TAP is intended to help 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.
To implement the TAP Pilot, the FDA intends to take a phased-enrollment approach throughout the duration of MDUFA V. The first phase is the TAP Pilot Soft Launch, which will be conducted during FY 2023 and begin on January 1, 2023. During the TAP Pilot Soft Launch phase, the FDA intends to enroll up to 15 devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices.
The TAP Pilot will include establishing a dedicated cadre of FDA advisors trained to provide proactive, dynamic, and strategic feedback and advice tailored to the specific needs of each developer who has a device in the program. TAP Pilot feedback can help developers improve the quality of their submissions, including a better understanding of the FDA’s expectations regarding generating evidence to support submissions.
By providing medical device developers with earlier and more frequent interactions with the FDA’s advisors and review teams, it will better enable prompt identification of device issues that might delay the FDA’s authorization, so those issues can be addressed earlier in the development process and improve the chances of faster authorization.