The U.S. Food and Drug Administration (FDA) announced that beginning October 1, 2023, the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).

As of July 31, 2023, the FDA has enrolled five devices in the TAP Pilot. The FDA is still accepting requests for FY 2023 for devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices.

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.

The TAP Pilot is intended to demonstrate the feasibility and benefits of process improvements to the FDA’s early interactions with participants and stakeholders that support the vision for TAP. Through the TAP Pilot, the FDA will provide 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; and
  • Collaborating to better align expectations regarding evidence generation, improve submission quality, and improve the efficiency of the premarket review process.

The long-term vision for TAP is to help spur more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance. A mature TAP is also intended to help ensure the sustained success of the Breakthrough Devices Program.

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