The Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot started in FY 2023 by the FDA’s Center for Devices and Radiological Health (CDRH). Their goal is to create an effective pathway for innovative medical devices to enter the market. Nine (9) medical devices from the Office of Health Technology 2: Office of Cardiovascular Devices are enrolled in the TAP Pilot program as of September 8, 2023. The goal for enrollees in FY 2023 is up to 15 devices. Beginning on October 1, 2023, the TAP Pilot expands to include devices reviewed in the Office of Neurological and Physical Medicine Devices. The goal is to enroll up to 45 additional devices through FY 2024.

The FDA is still receiving requests for devices reviewed in the Office of Cardiovascular Devices for FY 2023, encouraging qualifying devices to continue to apply. If your medical device meets these criteria, or the upcoming expansion into the Office of Neurological and Physical Medicine Devices, start the enrollment process now!

For assistance in understanding how to enroll in the TAP Pilot, DPDC is ready to connect! Reach out now for a free consultation.

For details about the TAP Pilot, its goals and timeline over the next few years, click here.