CDRH Launches the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot

| Stat One

The FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. The program is intended to promote early, frequent, and strategic communications between the FDA and medical device sponsors.  This will aid in ensuring that U.S. patients have access to high-quality, safe, effective, and innovative medical devices.

The FDA states the following goals of the TAP pilot below:

  • 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 FDA 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 FDA 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.

To read more about the program, click here.


Our team at Stat One always emphasizes the importance of early conversations when navigating factors such as study design, clinical program developments, and FDA interactions.  To speak with our biostatistical experts, contact