Oct 12 -- The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot that will begin in fiscal year (FY) 2023 with the initial phase, hereafter referred to as the TAP Pilot Soft Launch. The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the reauthorization of the Medical Device User Fee Amendments for FY 2023 through FY 2027 (MDUFA V). 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. Over the course of MDUFA V, the voluntary TAP Pilot is intended to demonstrate the feasibility and benefits of process improvements to FDA's early interactions with participants and of FDA's facilitation of interactions between participants and stakeholders that support the vision for TAP.
Beginning January 1, 2023, FDA is seeking requests for enrollment in the TAP Pilot Soft Launch for FY 2023. Either electronic or written comments on this notice must be submitted by January 10, 2023 to ensure that the Agency considers your comment on this notice before it begins work on the next phase of the TAP Pilot.
As part of the reauthorization of the MDUFA V, FDA committed to establish the TAP Pilot during the course of MDUFA V. 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 (see more information on this program below in Section I.C). Through the TAP Pilot, as described in the MDUFA V commitment letter, FDA will provide the following types of strategic engagement for innovative devices of public health importance:
• Improving participants' experiences with 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 (Ref. 1).
Consistent with the MDUFA V commitment letter, FDA initially intends to include only devices with a granted Breakthrough designation in the TAP Pilot in FY 2023-FY 2025 and intends to include devices with a granted Breakthrough designation or request for inclusion in the Safer Technologies Program (STeP) in FY 2026-FY 2027. At this time, devices regulated by the Center for Biologics Evaluation and Research (CBER) are outside the scope of the TAP Pilot. In addition, given the complexities involved with the review of combination products, including coordination with review staff outside of CDRH, we anticipate that it will be difficult for sponsors of combination products to benefit fully from the TAP Pilot. Therefore, at this time, we do not intend to enroll combination products in the Pilot.
To implement the TAP Pilot and in accordance with the MDUFA V commitment letter, FDA intends to take a phased-enrollment approach throughout the duration of MDUFA V. The first phase is the TAP Pilot Soft Launch, which will be conducted during FY 2023 (Ref. 1). During the TAP Pilot Soft Launch phase, FDA intends to enroll up to 15 devices in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices. Selection of OHT2 for the TAP Pilot Soft Launch was based on consideration of multiple factors, including OHT2's historical number of granted Breakthrough designations, workload, staffing levels, and expertise, as well as experience with review paradigms involving rapid interactions, such as Early Feasibility Studies. For example, OHT2 has granted 163 Breakthrough Device designations as of June 30, 2022, which represents 23.7 percent of the 687 Breakthrough Device designations granted by CDRH.
In subsequent fiscal years, FDA intends to expand the TAP Pilot to enroll more devices and to include devices reviewed in other OHTs. Specifically, as stated in the MDUFA V commitment letter, in FY 2024, the TAP Pilot will continue to support devices enrolled in the previous fiscal year and will expand to enroll up to 45 additional devices in at least two OHTs (i.e., up to 60 total devices enrolled through FY 2024). In FY 2025, the TAP Pilot will continue to support devices enrolled in previous fiscal years and will expand to enroll up to 65 additional devices in at least four OHTs (i.e., up to 125 total devices enrolled through FY 2025). In FY 2026 and FY 2027, the TAP Pilot will continue to support devices enrolled in previous fiscal years and will expand to enroll up to 100 additional devices each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from the FY 2023 to FY 2025 experience (i.e., up to 225 total devices enrolled through FY 2026 and up to 325 total devices enrolled through FY 2027). For FY 2024-FY 2027, selection of the OHTs will include consideration of the factors mentioned above regarding the selection of OHT2 for the Soft Launch, experience from prior years, and input from industry and other stakeholders (Ref. 1). For FY 2024-FY 2027, FDA plans to announce the OHT(s) selected for future participation in the TAP Pilot via the TAP Pilot web page no later than 30 days prior to the start of each fiscal year.
FDA will inform potential participants of the TAP Pilot as part of the Breakthrough designation process or request for inclusion in the STeP process, as applicable. Eligible TAP Pilot participants will be enrolled on a first-come, first-served basis. The Pilot's capacity for additional participating devices and the number of participating OHTs within CDRH will increase each fiscal year as described in Section I.A. As noted above, at this time, devices regulated by CBER are outside the scope of the TAP Pilot, and we do not intend to enroll combination products in the Pilot.
FDA intends to enroll devices reviewed in a participating OHT in the voluntary TAP Pilot using the following enrollment criteria, consistent with the MDUFA V commitment letter:
1. Devices will be those with either a granted Breakthrough designation or (during FY 2026 and FY 2027) a granted request for inclusion in the Safer Technologies Program (STeP);
2. Potential participants will not have submitted a Pre-Submission about the device after being granted a Breakthrough designation or inclusion in STeP;
3. 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
4. Each potential participant will have a maximum of one device enrolled in the TAP Pilot per fiscal year.
Enrollment in the TAP Pilot, including in the Soft Launch, does not change any statutory or regulatory requirements that may apply to the TAP Pilot device or participant, including, but not limited to, investigational device exemption (IDE) requirements under 21 CFR part 812; premarket notification requirements under 21 CFR part 807, subpart E; premarket approval requirements under 21 CFR part 814; and/or De Novo classification requirements under 21 CFR part 860, subpart D. It is the sponsor's responsibility to ensure compliance with applicable laws and regulations.
FDA understands that to make this program the most effective, we will need additional feedback and suggestions from industry and other stakeholders. FDA encourages all stakeholders to comment on the TAP Pilot generally. The Agency is particularly interested in feedback on the following topics:
1. TAP Pilot participation will expand to include additional Offices of Health Technology (OHTs) in FY 2024 through FY 2027. In what order do you believe additional OHTs should be included in the TAP Pilot? Please provide the reasons/rationale/justification to support your recommendations in your response.
2. The TAP Pilot is intended to facilitate improved strategic decision-making and better align expectations regarding evidence generation during device development, including through facilitating interactions between TAP participants and stakeholders, such as patients, providers, and payers. These interactions are voluntary and may, for example, help provide a better understanding of the current treatment options used to treat or manage a given condition, which outcomes are most important to patients and providers, how a new technology may fit into clinical care paradigms and patient lives, how patients and providers consider tradeoffs between anticipated benefits and risks, and the evidence that may help support clinical adoption and coverage.
(1) What additional questions or topics could patients, providers, and/or payers address that could help inform sponsors' strategic decision-making?
(2) Are there specific patient, provider, or payer organizations whose members may be well-suited and willing to provide insights regarding evidence generation strategies to sponsors who wish to obtain such input?
FRN:
https://www.federalregister.gov/d/2022-21835