Breakthrough device designation

Breakthrough Device Designation: FDA Program Guide

Breakthrough Device Designation is the FDA's voluntary program for devices that could treat or diagnose serious conditions more effectively than what is available today. This guide covers who qualifies, how to apply, what to include, and what designation does and does not change. It draws on the FDA's program page, current as of August 31, 2026.

Breakthrough Device Designation – FDA Fast-Track Pathway

The FDA introduced the Breakthrough Devices Program to speed up the development, assessment, and review of devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The aim is to get patients and clinicians timely access to them. The program applies to devices and device-led combination products, and it speeds up development and review for PMA approval, 510(k) clearance, and De Novo authorization. 

Two clarifications are worth making up front:

• It is not a separate marketing pathway. A designated device still goes through PMA, 510(k), or De Novo review. Breakthrough devices must still meet the FDA's standards for safety and effectiveness to be authorized. The "fast-track" label describes the faster, more interactive process, not a lower bar. 
• It replaced earlier programs. It replaced the Expedited Access Pathway and Priority Review for medical devices. 

As of June 30, 2026, CDRH and CBER had granted 1,320 Breakthrough Device designations. By then, 210 designated devices had received marketing authorization for an indication consistent with their designation. Designation is therefore a strong start, not a guarantee of authorization.

Eligibility Criteria for Breakthrough Device Designation

A device subject to a PMA, 510(k), or De Novo request is eligible if it meets both of the FDA's criteria. The criteria come from Section 515B of the FD&C Act. 

What Qualifies as a Breakthrough Device?

The first criterion. The sponsor must show a reasonable expectation that the device could treat or diagnose the condition named in the proposed indications for use more effectively than the current standard of care. Published literature or clinical data are two ways to show a realistic expectation of technical and clinical success.

Breakthrough technology. This second-criterion option applies to a device that represents a novel technology or a novel application of an existing technology, or that could improve clinical outcomes in the diagnosis, treatment (including monitoring), cure, mitigation, or prevention of a life-threatening or irreversibly debilitating disease or condition.

Example: A transcatheter heart valve delivered through the skin, avoiding open-heart surgery. It lowers procedural risk and could give a meaningful advantage to patients with few options.

Designation is granted for a specific device and its indication for use. If the device is later authorized for a different indication, it is not counted as a market-authorized Breakthrough Device.

Unmet Need and Available Alternatives

The other three options in the second criterion turn on what is already on the market.

No approved or cleared alternative exists. This applies when nothing legally marketed treats or diagnoses the serious condition.

Example: An ablation catheter with the potential to treat atrial fibrillation, at a time when catheters were approved for atrial flutter but none was indicated for atrial fibrillation.

Significant advantages over existing alternatives. The FDA looks at whether the device could, for example, lower hospitalization rates, improve patients' quality of life, help patients manage their own care, or provide long-term clinical efficiency.

Example: A product for a life-threatening or irreversibly debilitating condition that avoids a serious adverse effect associated with an available product.

Device availability is in the best interest of patients. This covers devices that address serious malfunctions in critical parts of existing devices, offer added benefits such as better patient engagement, respond to public health needs such as shortages or emergencies, or address a high risk of patient morbidity. The FDA's 2023 update to its guidance added provisions on health equity and non-addictive products. 

Example: An insulin pump with a new mechanism to detect and respond to low blood glucose.

Device Designation

Once a device is designated, the sponsor can use several options for feedback during development. These include sprint discussions, a discussion of the data development plan, and a request for clinical protocol agreement. Designated devices also receive prioritized review of future submissions, including Q-Submissions, IDE applications, and marketing submissions. 

Important points about designation:

• It is not public by default. Before marketing authorization, the FDA generally cannot say whether a sponsor requested designation or whether the request was granted or denied, unless the sponsor discloses it. The FDA lists designated devices only after they are authorized. 
• It survives competition. If another device with the same intended use is authorized first, the FDA will not revoke your designation on that basis alone. 
• It can be withdrawn. A sponsor may ask to withdraw from the program at any time, in writing. 
• If your device doesn't qualify, the FDA suggests considering the Safer Technologies Program (SteP), which is meant for devices that aren't intended for life-threatening or irreversibly debilitating conditions. 

How to Request for Breakthrough Device Designation

You request designation by submitting a "Designation Request for Breakthrough Device" Q-Submission. It should be the only request in that Q-Submission. You can send it online through the CDRH Customer Collaboration Portal. The PDF describes this as part of the Pre-Submission program. It is a specific type of Q-Submission, which is the FDA's umbrella process for feedback requests. 

The steps:

1. Check eligibility against both criteria, and be realistic about whether the evidence supports the request.
2. Choose your timing. You can send the request at any time before you send the marketing submission. Requests made during or after a marketing submission will not be reviewed. 
3. Prepare the request as a standalone Q-Submission and submit it through the CDRH Portal.
4. Respond quickly to FDA questions. The FDA intends to request any additional information within 30 days of receiving your request, and if it doesn't get needed information promptly, the request may be denied. 
5. Wait for the decision letter. You can expect a letter granting or denying the request within 60 calendar days of receipt. 
6. Use the Q-Submission reference number in all later communications with the FDA about the device.

There is no fee to submit a designation request, though the usual user fees still apply to the eventual 510(k), De Novo, or PMA submission. If a request is denied, the FDA explains why, and you can submit a new request that addresses the gaps. The FDA may also recommend the program to sponsors whose devices look like good candidates. 

What Should Be Included in the Designation Request:

The FDA recommends that your request include: 

• Information to describe the device: what it is, how it works, and its intended use
• The proposed indication for use: the condition, patient population, and conditions of use
• Regulatory history: any prior interactions, submissions, or marketing status
• How your device meets the statutory criteria: a point-by-point argument for the first criterion and at least one second-criterion option, supported by literature, nonclinical data, or clinical data
• The type of marketing submission you plan to submit: PMA, 510(k), or De Novo

Appendix 1 of the FDA's guidance gives further detail on what to include. Tips for a stronger request:

• Compare your device with the current standard of care and any existing alternatives, and be specific.
• Tie each claim to evidence rather than general statements.
• Keep the request focused on the designation criteria.

Evidence Requirements for Breakthrough Devices

There are two different evidence questions.

For designation. The FDA asks whether there is a reasonable expectation that the device could meet the criteria, which is a lower bar than proof. Because the decision comes before marketing authorization, literature, preclinical work, and early clinical data can all support the request.

For marketing authorization. The usual statutory standards still apply: reasonable assurance of safety and effectiveness for PMA and De Novo, and substantial equivalence for 510(k). The program does not change this. What it changes is the process and, in some cases, how uncertainty is weighed. In its benefit-risk analysis for Breakthrough Devices, the FDA may accept a greater degree of premarket uncertainty, balanced by adequate postmarket controls. In practice that can mean planned postmarket data collection to confirm long-term performance. 

Tools available after designation to plan the evidence:

• Data development plan: an optional, high-level plan for the nonclinical and clinical evidence across the product lifecycle.
• Sprint discussions: focused, time-limited discussions on specific issues.
• Clinical protocol agreement: agreement with the FDA on a clinical study protocol before you run it.

The type and amount of evidence still depends on the device, its risk, and the pathway.

Examples of Devices Which Received Breakthrough Device Designation:

Qualifying for Breakthrough Designation doesn't mean a device's submission pathway is De Novo by default. Designated devices have been authorized through PMA, De Novo, and 510(k). The dates below are marketing authorization decision dates, not designation dates. The FDA's list of market-authorized Breakthrough Devices shows ESPRIT BTK approved by PMA on April 26, 2024, Rho authorized by De Novo on April 9, 2024, and the i-STAT TBI cartridge cleared by 510(k) on March 27, 2024. 

Other devices on the FDA's list include Edwards' EVOQUE tricuspid valve replacement system (PMA, 02/01/2024), the FARAPULSE pulsed field ablation catheter for atrial fibrillation (PMA, 01/30/2024), Medtronic's Symplicity Spyral renal denervation system (PMA, 11/17/2023), Insulet's Omnipod 5 automated insulin delivery system (510(k), 01/27/2022), and IDx-DR (De Novo, 04/11/2018). 

Frequently Asked Questions

1. How long does FDA take to decide on a Breakthrough Device designation request?

The FDA decides within 60 calendar days of receiving your request, and it sends a decision letter granting or denying it. In practice:

• Around day 30: The FDA generally reaches out by email if it needs more information.
• Respond quickly: Missing or late information can lead to a denial.
• No fee and usually no meeting: There is no user fee for the request, and there is typically no meeting to discuss the decision. If the request is denied, the FDA gives a written rationale, and you can submit a new request that addresses the gaps.
• Timing: Submit the request before your FDA 510(k), De Novo, or premarket approval (PMA) submission. A request made after a marketing submission is filed will not be reviewed.

While you wait, keep working on the parts of your file that the review will rely on. That includes the ISO 14971 risk file and early usability engineering results, such as formative evaluation findings.

2. Can a device lose its Breakthrough Device designation?

Designation is granted for a specific device and indication for use, and it is fairly durable:

• A competitor does not remove it. If another device with the same intended use is authorized first, the FDA will not revoke your designation solely for that reason. A new applicant in that situation, however, must show it offers a significant advantage.
• You can withdraw. A sponsor may ask to withdraw from the program at any time, in writing.
• A change in indication matters. If a designated device is later authorized for a different indication than the one it was designated for, it is not counted as a market-authorized Breakthrough Device. If you plan to change the intended use or the design significantly, ask the FDA how it affects your designation.

Designation is also not a regulatory classification. Medical device classification (Class I, II, or III) and your marketing pathway still apply separately.

3. Does Breakthrough Device designation reduce the clinical evidence required for FDA approval?

No. The statutory standards are unchanged: reasonable assurance of safety and effectiveness for PMA and De Novo, and substantial equivalence for a 510(k). Breakthrough devices must still meet the FDA's standards to be authorized.

What changes is the process and, in some cases, how uncertainty is weighed:

• Benefit-risk: For PMA and De Novo, the FDA may accept a somewhat greater degree of premarket uncertainty when it is balanced by adequate postmarket controls, such as planned data collection after launch.
• Planning tools: Designated devices can use sprint discussions, a data development plan, and a request for clinical protocol agreement, so evidence questions are settled early.
• Nothing else gets lighter: You still need design and development records under ISO 13485 and 21 CFR Part 820, an ISO 14971 risk file, and IEC 62304 documentation for software. Usability engineering evidence, including formative and summative evaluation, is also unchanged.
• Other markets: The designation is a U.S. program. In the EU, evidence is assessed separately, and the clinical evaluation report (CER) is a distinct MDR requirement.

4. How is Breakthrough Device designation different from FDA Priority Review?

The Breakthrough Devices Program replaced the earlier device Priority Review program and the Expedited Access Pathway. Priority Review only gave prioritized handling of a premarket submission. Breakthrough covers the whole development path:

Designated devices still have to meet the same authorization standards. Do not confuse this with "priority review" in the drug world, which is a separate designation with different timelines.

For a designated device, keep your device identification consistent. The version and model you test and submit should match your labeling and your GUDID record.