Written and maintained by CASRAI Editorial Board
Last updated
The FDA Total Product Life Cycle Advisory Program (TAP) is a strategic regulatory and market-access initiative established by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) under the Medical Device User Fee Amendments of 2022 (MDUFA V). Launched as a phased pilot on January 1, 2023, TAP is designed to bridge the “valley of death” between FDA marketing authorization and real-world clinical adoption for high-impact medical devices and Software as a Medical Device (SaMD). By layering proactive, multi-stakeholder advisory services onto the statutory FDA Breakthrough Device Designation (FD&C Act Section 515B) and Safer Technologies Program (STeP), TAP coordinates FDA premarket review expectations with clinical society coding and payer coverage requirements alongside programs from the FDA Digital Health Center of Excellence and Medical Device Development Tools (MDDT).
What Is the FDA Total Product Life Cycle Advisory Program (TAP) and How Does It Build on the Breakthrough Devices Program?
Historically, innovative medical device sponsors designed pivotal clinical investigations solely to satisfy FDA’s statutory threshold of “reasonable assurance of safety and effectiveness” (for Premarket Approval [PMA] or De Novo requests) or “substantial equivalence” (for 510(k) submissions). Once cleared or approved, many devices encountered multi-year delays in patient access because the pivotal trial endpoints, comparator arms, or follow-up durations did not satisfy the evidentiary requirements of the Centers for Medicare & Medicaid Services (CMS) or commercial health plans (“reasonable and necessary” under Social Security Act § 1862(a)(1)(A)).
Under the MDUFA V Commitment Letter (FY 2023–FY 2027), CDRH launched the TAP Pilot to provide continuous, solutions-focused engagement across the entire product development lifecycle. Phased enrollment across CDRH Offices of Health Technology (OHTs) progressed as follows:
- FY 2023 (Year 1): Launched in OHT7 (Office of Cardiovascular Devices) for up to 15 Breakthrough-designated devices.
- FY 2024 (Year 2): Expanded to OHT6 (Office of Orthopedic Devices) and OHT8 (Office of Neurological and Physical Medicine Devices) for up to 60 total devices.
- FY 2025–FY 2027 (Years 3–5): Expanded to include OHT1 (Ophthalmic, Anesthesia, Respiratory, ENT, and Dental), OHT2 (Cardiovascular/Renal/Gastro/Urological), OHT3 (Obstetrical/Gynecological/Radiological), OHT4 (Surgical and Infection Control), and OHT5 (In Vitro Diagnostics / Radiological Health), scaling toward a cumulative MDUFA V goal of up to 325 enrolled devices and opening eligibility to selected Safer Technologies Program (STeP) devices.
To enroll in TAP, a sponsor must hold an active Breakthrough Device Designation or STeP acceptance in a participating OHT, be in early device development (prior to submitting a pivotal Investigational Device Exemption [IDE] or premarket marketing submission), and request enrollment within the designated timeframe after designation.
What Are the Statutory Criteria and Sprint Discussion Workflows for the FDA Breakthrough Devices Program?
Because Breakthrough Device Designation under Section 515B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. § 360e-3) is the primary gateway into TAP, sponsors must first satisfy two statutory criteria in a Designation Request Q-Submission (reviewed by FDA within 60 calendar days):
| Statutory Requirement (21 U.S.C. § 360e-3(b)) | Mandatory Sub-Elements | Interactive Review & Sprint Workflow |
|---|---|---|
| Criterion 1 (Mandatory) | The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions | Evaluated based on biological plausibility, bench/animal data, or preliminary clinical evidence |
| Criterion 2 (Must meet at least ONE of 2A–2D) | (A) Represents breakthrough technology; (B) No approved or cleared alternatives exist; (C) Offers significant clinically meaningful advantages over existing alternatives; OR (D) Device availability is in the best interest of patients | Unlocks priority review, senior management involvement, 45-day Sprint Discussions on focused single topics, and a holistic Data Development Plan (DDP) |
Once designated, sponsors can initiate Sprint Discussions—accelerated 45-calendar-day interactive Q-Submissions focused on a single technical or clinical topic (such as animal study protocols, software verification/validation, or pivotal clinical trial statistical analysis plans)—and negotiate premarket/postmarket data balance through a formal Data Development Plan (DDP).
How Does the TAP Pilot Facilitate Early Coordination with Payers, Clinical Societies, and FDA CDRH Reviewers?
For devices enrolled in the TAP Pilot, CDRH assigns a dedicated TAP Advisor who provides rapid, strategic touchpoints beyond standard Q-Submission meetings and coordinates multi-stakeholder alignment across three non-regulatory pillars:
- Payer & CMS Coverage Evidence Alignment: Helps sponsors incorporate health economic and outcomes research (HEOR) endpoints, Medicare-representative patient demographics (age ≥ 65 and disabled beneficiaries), and durability follow-up windows into the single pivotal IDE trial so the study simultaneously supports FDA marketing authorization and CMS coverage pathways such as Transitional Coverage for Emerging Technologies (TCET).
- Medical Professional Society Engagement (Coding & Clinical Guidelines): Connects developers early with specialty clinical societies (such as ACC, AAOS, AAN, or HRS) to evaluate Current Procedural Terminology (CPT) Category III to Category I coding pathways, physician workflow integration, and future clinical practice guideline inclusion criteria.
- Patient Group & Human Factors Input: Facilitates early consultation with patient advocacy organizations to integrate patient-reported outcome measures (PROMs) and patient preference information (PPI) into benefit-risk determinations.
Under MDUFA V performance goals, CDRH tracks quantitative timeliness metrics for TAP participants, including responding to at least 90% of requests for informal teleconferences on TAP-identified topics within 14 days and holding requested teleconferences within 40 days.
Frequently Asked Questions
What is the FDA Total Product Life Cycle Advisory Program (TAP) and how does it build on the Breakthrough Devices Program?
The Total Product Life Cycle Advisory Program (TAP) is a voluntary initiative launched by the FDA Center for Devices and Radiological Health (CDRH) on January 1, 2023, under the Medical Device User Fee Amendments (MDUFA V). TAP builds on the Section 515B Breakthrough Devices Program and Safer Technologies Program (STeP) by pairing early-stage device innovators with dedicated FDA TAP Advisors to proactively align regulatory, clinical trial, and payer reimbursement evidence.
What are the statutory criteria and sprint discussion workflows for the FDA Breakthrough Devices Program?
Under Section 515B of the FD&C Act (21 U.S.C. § 360e-3), a device must satisfy two criteria: Criterion 1 (provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions) and Criterion 2 (represent a breakthrough technology, no approved/cleared alternatives exist, offer significant advantages over existing alternatives, or availability is in the best interest of patients). Designated sponsors gain access to 45-day Sprint Discussions and coordinated Data Development Plans (DDPs).
How does the TAP pilot facilitate early coordination with payers, clinical societies, and FDA CDRH reviewers?
Unlike traditional Q-Submission feedback limited strictly to FDA marketing authorization requirements, TAP Advisors help sponsors identify non-regulatory adoption barriers early, facilitating voluntary engagement with patient organizations, medical professional societies (regarding clinical practice guidelines and CPT coding), and commercial and public payers (including CMS Transitional Coverage for Emerging Technologies [TCET]).
Sources
- U.S. Food and Drug Administration (FDA). Total Product Life Cycle Advisory Program (TAP). https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap
- U.S. Food and Drug Administration (FDA). Breakthrough Devices Program — Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program
- United States Code. 21 U.S.C. § 360e-3 — Breakthrough Devices (FD&C Act Section 515B). https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e-3&num=0&edition=prelim
