We support medical device and IVD manufacturers from the eligibility check through the designation request to sprint discussions, data development plan and enrollment in TAP. The designation changes how you work with the FDA; the standard for 510(k), De Novo or PMA stays the same.
Overview
Breakthrough Device designation and TAP for medical devices and IVD · FD&C Act Sec. 515B (21 U.S.C. 360e-3) · FDA guidance Breakthrough Devices Program · TAP pilot under MDUFA V (87 FR 61605)
Last updated: November 1, 2026
The FDA decides on a designation within 60 calendar days and on a reasonable expectation, without a complete set of clinical data (FD&C Act Sec. 515B(d)(1), guidance of September 15, 2023). What the request must show is narrower than many manufacturers assume, and so is what the designation decides.
Industries
Services
Assessment of the first criterion in its three parts (more effective, life-threatening, irreversibly debilitating) and of which of the four alternatives of the second criterion holds, each against the current US standard of care for the proposed indication. Deliverable: a reasoned assessment per criterion with the literature and preliminary bench, animal or clinical data that support technical and clinical success.
Building the request along the example in appendix 1 of the guidance: device description, proposed indications for use, regulatory history with IDE, 513(g) and Q-Submission numbers, the rationale for both criteria and the planned marketing submission with its reason. Submitted as a “Designation Request for Breakthrough Device” Q-Submission, followed by answers to the FDA within the 60 days.
Preparing sprint discussions with one topic, defined goals, an agreed schedule and draft minutes from the sponsor; a data development plan that sets out non-clinical and clinical data before and after marketing; where useful, a clinical protocol agreement under Sec. 515B(e)(2)(D) that binds both sides in writing.
Checking the FDA enrollment criteria before the first sprint or Pre-Submission, then the request as an amendment to the Q-Submission under which the designation was granted, with the subject “TAP Pilot Request for Enrollment”, sponsor name and address and the Q-Submission number. The FDA intends to answer in writing within 30 days.
How we work together
The Breakthrough Devices Program is not a pathway of its own. Under FD&C Act Sec. 515B it expedites the development and review of devices that still go through a PMA, a 510(k) or a De Novo request; the criteria and standards of those procedures stay untouched (Sec. 515B(g)(1)). What changes is the way of working: a review team with a team leader, oversight by senior management, interactive communication and priority review (Sec. 515B(e)(1)).
For a PMA, the statute adds options the FDA may use with the sponsor: early agreement on a data development plan, efficient and flexible trial designs and timely postmarket data collection (Sec. 515B(e)(2)). Under the guidance of September 15, 2023, the FDA may accept a greater extent of uncertainty in the benefit-risk profile at approval, where the benefit of earlier access and adequate postmarket controls balance it.
TAP builds on the designation. The Total Product Life Cycle Advisory Program is a CDRH pilot from the MDUFA V commitments. FDA advisors accompany enrolled devices and bring in parties outside the FDA, for example patient organizations, specialty societies and payers.
| Breakthrough Devices Program | TAP | |
|---|---|---|
| Basis | statute, FD&C Act Sec. 515B | pilot under the MDUFA V commitments, fiscal years 2023 to 2027 (87 FR 61605) |
| Entry | designation request as a Q-Submission, decision within 60 calendar days | amendment to the designation or STeP Q-Submission, FDA answer intended within 30 days |
| Scope | devices and device-led combination products at CDRH and CBER, for PMA, 510(k) or De Novo | Breakthrough or STeP devices that meet the enrollment criteria, places limited per fiscal year |
| What it offers | sprint discussions, data development plan, clinical protocol agreement, priority review | TAP advisors, set response times, contact with patients, specialty societies and payers |
Outside this page are the choice between the pathways and the criteria of the Safer Technologies Program on the page FDA Strategy & Pathways, the Q-Submission as a procedure on the page Q-Submission Program, and the three pathways themselves on the pages 510(k) Premarket Notification, De Novo Classification and Premarket Approval (PMA).
Our approach
Step
Result
Check eligibility
An assessment against both criteria and the current US standard of care, with a decision for Breakthrough, for the Safer Technologies Program or for neither.
Fix the sequence
A written order of TAP request, sprint discussions, data development plan and Pre-Submissions, agreed before the first of them is filed.
File the request
A Q-Submission with one device and one intended use, FDA questions answered by about day 30, a decision within 60 calendar days.
Use the program
A data development plan coordinated with the FDA, documented sprint outcomes and, where agreed, a clinical protocol agreement in writing.
Submit with priority
A marketing submission with priority review that meets the unchanged standard of the chosen pathway.
Common pitfalls
Priority review is planned as a shorter timeline.
The guidance places a designated submission at the top of the review queue with additional resources as needed, and it states that, from the FDA's experience, review times may be longer for Breakthrough devices because of the novel scientific issues they raise.
Sprint feedback is read as an approval.
The FDA intends its feedback not to change if later data are consistent and raise no important new issues, but a sprint does not guarantee approval, clearance or a grant. Only the clinical protocol agreement binds both sides, and even it yields to a written decision of the office director on a substantial scientific issue (Sec. 515B(e)(2)(D)).
The indication drifts between designation and marketing submission.
The designation is granted for a device and its indication for use; if the device is authorized for a different indication, the FDA does not consider it a market-authorized Breakthrough device and does not list it as one.
Another Breakthrough device with the same intended use is authorized first.
The FDA does not withdraw existing designations solely for that reason (Sec. 515B(d)(3)), but once a Breakthrough device is approved, cleared or granted, a new request for the same intended use must meet the criteria in light of that device's market availability.
The device is headed for a Humanitarian Device Exemption.
The guidance opens the program only to PMA, 510(k) and De Novo; the HDE pathway is not eligible.
Regulatory Affairs
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
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Projects from this industry
Latest insights
All insights →FDA Strategy & Pathways →
Choosing between 510(k), De Novo and PMA, with Q-Sub, STeP and TAP as instruments
Q-Submission Program →
The Q-Submission that carries the designation request, sprints and the TAP request
Premarket Approval (PMA) →
The PMA itself: clinical evidence, modular submission, filing, panel and conditions
De Novo Classification →
The route for novel low to moderate risk devices without a predicate
510(k) Premarket Notification →
Predicate, substantial equivalence, tests, eSTAR and review of a 510(k)
Health Authority Interaction →
Meetings with the FDA from the Pre-Submission onward
Clinical Compliance →
Clinical investigations whose design the program can make more flexible
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
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