On October 2, 2023, the FDA announced the voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot is now accepting enrollment requests for both the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5).
As of February 1, 2024, the FDA has enrolled 31 devices in the TAP Pilot.
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 for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors.
The TAP Pilot is one of the commitments between the FDA and industry as part of the MDUFA V reauthorization.
Watch Dr. Jeff Shuren, Director of CDRH, discuss the TAP Pilot below (recorded July 2023).
On this page:
- Goals of the TAP Pilot
- TAP Pilot Enrollment and Expansion Schedule
- TAP Pilot Enrollment Criteria and Process
- TAP Collaborating Organizations
- Performance Metrics
- TAP Pilot Feedback and Questions
- TAP Pilot News
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 non-FDA 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.
To implement the TAP Pilot, the FDA is taking a phased-enrollment approach throughout the duration of MDUFA V.
During FY 2023, the FDA will enroll up to 15 devices reviewed in the Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices.
Beginning October 1, 2023 (FY 2024), the TAP Pilot will also include devices reviewed in the Office of Health Technology 5 (OHT5): Office of Neurological and Physical Medicine Devices. In FY 2024, the TAP Pilot will continue to support devices enrolled during FY 2023 and will expand to enroll up to 45 additional devices (that is up to 60 total devices enrolled through FY 2024) across the participating OHTs.
The FDA intends to expand the TAP Pilot to enroll more devices and to include devices reviewed in other OHTs using the following schedule outlined in the MDUFA V commitment letter:
- 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 (that is up to 125 total devices enrolled through FY 2025); and
- 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 (that is 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 OHT’s historical number of granted Breakthrough designations, workload, and available staffing and expertise; experience from prior years; and input from industry and other stakeholders.
The FDA plans to announce the OHT(s) selected for future participation in the TAP Pilot on this web page no later than 30 days prior to their inclusion in the Pilot.
The FDA will inform potential participants of the TAP Pilot at the time the Breakthrough Device designation is granted if the reviewing OHT is actively participating in the TAP Pilot at that time. The TAP Pilot’s capacity for additional participating devices and the number of participating OHTs within CDRH will increase each fiscal year as described above. Devices regulated by the Center for Biologics Evaluation and Research (CBER) are outside the scope of the TAP Pilot. Also, CDRH does not intend to enroll combination products in the TAP Pilot at this time.
FDA intends to enroll devices reviewed in a participating OHT in the voluntary TAP Pilot 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.
*In FY2026-27, devices with a granted request for inclusion in the Safer Technologies Program (STeP) may also be eligible.
Starting October 1, 2023, the FDA will accept enrollment requests for devices reviewed in OHT2 and OHT5.
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, on this web page.
The TAP Pilot is designed to provide TAP participants with earlier and more frequent interactions with CDRH, and more strategic engagement with non-FDA stakeholders to help spur more rapid development as well as more timely and widespread patient access to safe, effective, high-quality medical devices of public health importance. Through the TAP Pilot, TAP participants may benefit from the following types of engagement for innovative devices:
- Regular, solutions-focused engagement between FDA participants, and other non-FDA stakeholders
- Better aligned expectations regarding evidence generation
- Enhanced experience of TAP participants, non-FDA stakeholders and FDA participants
- Improved strategic decision-making during device development, including earlier identification, assessment, and mitigation of device development risk
- Improved TAP participants’ experiences with the FDA
As part of the TAP Pilot, a TAP participant may request early interactions with non-FDA stakeholders. When these requests are made, CDRH may facilitate engagement between TAP participants and non-FDA stakeholders. However, CDRH does not design, establish, convene, or run the engagements. TAP participants may consider requesting strategic input in areas such as 1) obtaining clinical adoption of their device; 2) incorporating their device therapy into professional guidelines; 3) publication; 4) obtaining coding, coverage, and payment for their device; and/or 5) measuring outcomes that are important to patients and health care providers.
It is anticipated that these early, proactive, solutions-oriented engagements may help TAP participants better address challenges to widespread adoption of their innovative device. This input may be of significant value throughout device design and development, during clinical trials, and (if applicable) post FDA-authorization, by increasing predictability and reducing the time and cost of device development from concept to commercialization.
The collaborating organizations listed below have formally agreed to participate in the TAP Pilot.
- American Academy of Physical Medicine and Rehabilitation (AAPMR)
- American Association of Neurological Surgeons (AANS)
- American Association of Kidney Patients (AAKP)
- American Brain Coalition (ABC)
- American College of Cardiology (ACC)
- American Epilepsy Society (AES)
- American Heart Association
- American Medical Association (AMA)
- American Society of Clinical Psychopharmacology (ASCP)
- American Society of Echocardiography (ASE)
- American Society of Interventional Pain Physicians (ASIPP)
- American Society of Pain and Neuroscience (ASPN)
- The American Society of Pediatric Neurosurgeons (ASPN)
- Congenital Heart Surgeons’ Society (CHSS)
- Congress of Neurological Surgeons (CNS)
- COPD Foundation
- Epilepsy Foundation
- Heart Rhythm Society (HRS)
- International Children's Advisory Network (iCAN)
- The Mended Hearts, Inc. (MHI)
- The Michael J. Fox Foundation for Parkinson's Research (MJFF)
- Muscular Dystrophy Association (MDA)
- National Organization for Rare Diseases (NORD)
- North American Neuromodulation Society (NANS)
- North American Spinal Cord Injury Consortium (NASCIC)
- Pediatric and Congenital Interventional Cardiovascular Society (PICS)
- Society for Cardiovascular Angiography and Interventions (SCAI)
- Society for Vascular Surgery (SVS)
- The Society of Neurological Surgeons (SNS)
- Society of Thoracic Surgeons (STS)
- Spina Bifida Association (SBA)
Beginning in FY 2024, the following quantitative performance metrics are being tracked to achieve TAP Pilot objectives:
- 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, starting in FY 2024, the FDA will assess the TAP Pilot using an independent third party (or parties). This assessment will include a participant survey and quantitative and qualitative success metrics 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.
The FDA encourages all stakeholders, including Pilot participants, to provide feedback on the TAP Pilot. Feedback or questions about the voluntary TAP Pilot may be submitted to TPLC-Advisory-Program@fda.hhs.gov.
- CDRH Statement – October 2, 2023
- CDRH Statement – October 11, 2022
- Federal Register: Medical Devices; Voluntary Total Product Life Cycle Advisory Program Pilot, October 11, 2022