Introduction
The Soft Launch phase of the Total Product Life Cycle Advisory Program (TAP) TAP Pilot will 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 FDA’s Center for Devices and Radiological Health (CDRH) has launched the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. 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.
Goals of the TAP Pilot
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 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.
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.
FY 2023 Enrollment Criteria
For the TAP Pilot Soft Launch in FY 2023, the FDA intends to enroll up to 15 devices in the Office of Cardiovascular Devices (OHT2) using the following enrollment criteria:
- Devices will be those with a granted Breakthrough Device designation;
- Potential participants will not have submitted a Pre-Submission about the device after being granted a Breakthrough Device designation;
- Devices will be early in their device development process (e.g., have not yet initiated a pivotal study for the device) at time of enrollment; and
- Each potential participant will have a maximum of one device enrolled in the TAP Pilot per fiscal year.
FY 2023 Enrollment Process
Beginning January 1, 2023, the FDA is seeking requests for enrollment in the TAP Pilot Soft Launch for FY 2023. To have a device considered for enrollment, sponsors should submit an amendment to the Q-submission under which their device was granted Breakthrough designation, with the following information:
- A subject heading clearly indicating “TAP Pilot Request for Enrollment”;
- Name and address of the device sponsor; and
- The Q-Submission number under which the device proposed for enrollment in the TAP Pilot was granted Breakthrough Device designation.
Following receipt of a request for enrollment in the TAP Pilot, the FDA intends to consider the request using the enrollment criteria outlined above until the TAP Pilot has reached capacity for the fiscal year. Eligible TAP Pilot participants will be enrolled on a first-come, first-served basis. Within 30 days of receipt, the FDA intends to notify the potential participant in writing whether or not the device has been enrolled into the TAP Pilot.
- If a participant’s device is enrolled into the TAP Pilot, the FDA will contact the participant to schedule an initial meeting to provide an overview of the TAP Pilot processes, expectations, and engagement opportunities.
- If, after review of a request for enrollment, a device is not enrolled in the TAP Pilot, the FDA will identify the reason(s) for that decision.
If the maximum number of devices has been enrolled for the fiscal year in which a request is received, the FDA intends to notify the sponsor submitting the request that enrollment in the TAP Pilot has reached capacity for the current fiscal year. The FDA also intends to provide enrollment updates, including a notification that we have reached capacity for a given fiscal year.
Performance Metrics
To achieve the TAP Pilot objectives, the FDA has committed to implement and track the following quantitative performance metrics, beginning in FY 2024:
- CDRH will engage in a teleconference with the participant on requested topic(s) pertaining to the TAP device within 14 days of the request for 90% of requests for interaction.
- CDRH will provide written feedback on requested biocompatibility and sterility topics(s) pertaining to the TAP device within 21 days of the request for 90% of such requests for written feedback.
- CDRH will provide written feedback on requested topic(s) pertaining to the TAP device other than biocompatibility and sterility within 40 days of the request for 90% of requests for written feedback.
For informational purposes, the FDA will conduct an assessment of the TAP Pilot using an independent third party (or parties). This assessment will include a participant survey and quantitative and qualitative success metrics, starting in FY 2024, that include but are not limited to:
- the extent to which the FDA is successful at meeting the quantitative goals described above;
- participant satisfaction with the timeliness, frequency, quality, and efficiency of interactions with and written feedback from the FDA;
- participant satisfaction with the timeliness, frequency, quality, and efficiency of voluntary interactions with non-FDA stakeholders facilitated by the FDA (if utilized); and
- an overall assessment of the outcomes of the Pilot and opportunities for improvement.
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