Medical Innovation Exchange

FDA Announces Expansion of Total Product Life Cycle Advisory Program Pilot



Beginning October 1, 2023, the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include Neurological and Physical Medicine Devices.

The FDA’s Center for Devices and Radiological Health (CDRH) developed the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to help ensure that U.S. patients have access to high-quality, safe, effective and innovative medical devices first in the world by promoting early, frequent and strategic communications between the FDA and medical device sponsors.

Through the TAP Pilot, the FDA provides the following types of strategic engagement for innovative devices of public health importance:

  • Improving participants’ experiences with the FDA by providing for more timely premarket interactions
  • Enhancing the experience of all participants throughout the device development and review process, including the FDA’s staff
  • Facilitating improved strategic decision-making during device development, including earlier identification, assessment, and mitigation of device development risk
  • Facilitating regular, solutions-focused engagement between the FDA’s review teams, participants and other stakeholders, such as patients, providers and payers, beginning early in device development
  • Collaborating to better align expectations regarding evidence generation, improve submission quality, and improve the efficiency of the premarket review process.

In 2023, the FDA intends to enroll up to 15 devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices. As of July 31, 2023, the FDA had enrolled five devices in the TAP Pilot.

The current expansion is first of several expansions planned for the program over the next three years. Learn more about the TAP Pilot enrollment process here.

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