FDA Breakthrough Device Designation: Complete Guide to the Breakthrough Devices Program (2026)
Everything you need to know about FDA Breakthrough Device Designation — eligibility criteria, application process via Q-Submission, program benefits, statistics, timeline, and how it applies to 510(k), De Novo, and PMA pathways.
What Is the FDA Breakthrough Devices Program?
The FDA Breakthrough Devices Program is a voluntary program designed to expedite the development, assessment, and review of certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program provides patients and healthcare providers with timely access to these devices by facilitating manufacturer interaction with FDA experts, enabling flexible clinical study designs, and prioritizing regulatory review.
Legal Basis and History
The Breakthrough Devices Program was established by Congress through the 21st Century Cures Act, specifically Section 3051, which added Section 515B to the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 360e-3). The program replaced two earlier expedited pathways:
- Expedited Access Pathway (EAP): Created in 2014 by FDA guidance, the EAP was the first formal mechanism for prioritizing novel device reviews. Devices designated under the EAP are now considered part of the Breakthrough Devices Program, and the FDA counts them in its program statistics.
- Priority Review Program for Devices: The earlier priority review mechanism was absorbed into the Breakthrough Devices Program when it launched.
The FDA published the original final guidance document for the Breakthrough Devices Program on December 18, 2018. This guidance was subsequently updated on September 15, 2023, with significant new provisions addressing health equity and non-addictive products.
The program is administered primarily by the Center for Devices and Radiological Health (CDRH), with the Center for Biologics Evaluation and Research (CBER) handling certain device-led combination products.
Critical distinction: Breakthrough Device Designation is not an alternative regulatory pathway. Designated devices still must go through 510(k), De Novo, or PMA review and meet the same statutory standards for clearance or approval. The designation provides process efficiencies and enhanced FDA interaction — not a lower evidence standard.
Eligibility Criteria: Who Qualifies for Breakthrough Device Designation?
To receive Breakthrough Device Designation (BDD), a device must meet two statutory criteria established in Section 515B(b) of the FD&C Act.
Criterion 1: Life-Threatening or Irreversibly Debilitating Condition (Required)
The device must target a disease or condition that is:
- Life-threatening: Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted, or where there is a potential for premature death. Examples include certain cancers, severe heart failure, and acute stroke.
- Irreversibly debilitating: Diseases or conditions that cause serious, permanent deterioration of health or function that cannot be reversed. Examples include ALS, advanced Parkinson's disease, and progressive neurodegenerative conditions.
Criterion 1, Part 2: "More Effective" Treatment or Diagnosis (Required)
The device must provide a reasonable expectation that it could offer more effective treatment or diagnosis compared to the current standard of care (SOC) in the United States. FDA evaluates this based on the totality of available information. A complete set of clinical data is not required at the designation stage — the sponsor must demonstrate a reasonable expectation of both:
- Technical success: The device can function as intended (supported by bench, animal, or preliminary clinical data)
- Clinical success: A functioning device could more effectively treat or diagnose the identified disease or condition (supported by literature or preliminary data)
Criterion 2: At Least One of Four Sub-Criteria (Required)
In addition to Criterion 1, the device must meet at least one of the following:
| Sub-Criterion | Description | Example |
|---|---|---|
| (A) Breakthrough Technology | Represents a novel technology or a novel application of an existing technology that has the potential to lead to clinical improvement | A transcatheter heart valve delivered transcutaneously without open-heart surgery |
| (B) No Approved/Cleared Alternatives Exist | No legally marketed device has been approved or cleared for the same intended use | An ablation catheter for atrial fibrillation when only flutter catheters were cleared |
| (C) Significant Advantages Over Existing Alternatives | Offers clinically meaningful advantages over currently available options, including reduced hospitalization, improved quality of life, patient self-management, or long-term clinical efficiencies | A device that eliminates the need for weekly hospital visits by enabling at-home monitoring |
| (D) Device Availability Is in the Best Interest of Patients | Addresses an unmet medical need where the benefits outweigh the risks for the target population, or addresses an emerging public health need | A device addressing a critical shortage or designed to mitigate an unanticipated failure in an approved device |
A device does not need to meet all four sub-criteria. Meeting just one, in combination with Criterion 1, is sufficient.
General Eligibility Requirements
Beyond the designation criteria, the following requirements apply:
- Device type: Only medical devices and device-led combination products are eligible. Drug-led combination products are excluded.
- Marketing pathway: The device must be intended for future marketing authorization via PMA, De Novo, or 510(k). Devices exempt from these pathways are not eligible.
- Timing: The designation request must be submitted before the marketing application (PMA, 510(k), or De Novo). FDA will not accept a BDD request that arrives with or after the marketing submission.
- One device per request: Each designation request should cover only one proposed device and intended use.
2023 Updated Guidance: What Changed
On September 15, 2023, the FDA published an updated final guidance document that significantly expanded the scope and interpretation of the Breakthrough Devices Program. The designation criteria in statute (Section 515B) were not changed, but FDA's interpretation and application of those criteria were broadened.
Health Equity Considerations
The most significant update introduced explicit consideration of health and healthcare disparities into the designation evaluation. When assessing eligibility, FDA now considers:
- Technologies and device features that address disparities: Devices tailored to populations that exhibit health disparities, where treatment outcomes differ by race, ethnicity, sex, age, disability, or other factors
- Pathophysiological differences: Devices designed to address characteristic differences in disease presentation across populations (e.g., a pulse oximeter calibrated for accuracy across skin tones)
- Improved accessibility: Devices that enable effective treatment in diverse settings, including underserved communities, rural areas, or resource-limited environments
- Patient population-specific benefits: Devices designed for rare conditions with limited treatment options in specific demographic groups
FDA defines health equity using the World Health Organization definition: "the absence of unfair, avoidable and remediable differences in health status among groups of people."
Non-Addictive Products for Pain and Addiction
Consistent with the agency's obligations under Section 3001 of the SUPPORT for Patients and Communities Act (SUPPORT Act), the updated guidance clarifies that the Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction. This opens the program to devices that could serve as alternatives to opioid-based treatments.
Improved Accessibility as a Factor
The guidance clarifies that when evaluating whether a device may provide "more effective" treatment or diagnosis (Criterion 1), FDA may consider whether the device's features could allow for improved accessibility. For example, if a device can be used effectively in diverse clinical settings such that a patient population with limited or no available treatment options may have improved adherence to a prescribed medical regimen, this could support meeting the first designation criterion.
Program Benefits: What You Get with Breakthrough Designation
Breakthrough Device Designation provides a comprehensive set of process and interaction benefits that span the entire device development lifecycle.
Development Phase Benefits
- Interactive and sprint discussions: Ongoing, iterative communication with FDA experts throughout device development, beyond what is available through standard pre-submissions
- Pre-submission meetings: Expedited scheduling of pre-submission meetings to discuss clinical protocols, study endpoints, and regulatory strategy
- Clinical protocol feedback: Detailed FDA feedback on proposed clinical study designs, including the use of novel endpoints, surrogate endpoints, adaptive trial designs, and Bayesian approaches
- Data development plan: Collaboration with FDA on a data development plan that efficiently addresses regulatory requirements while potentially leveraging post-market data collection
Review Phase Benefits
- Priority review: Marketing submissions from designated devices receive priority assignment and are moved ahead of non-breakthrough submissions in the review queue
- Senior FDA management involvement: Senior managers within the review division and office participate in the review process, providing additional oversight and facilitating timely resolution of scientific disagreements
- Organizational commitment: FDA assigns a case manager and ensures that review resources are prioritized for breakthrough devices
- Flexible study designs: FDA may accept novel clinical study approaches, including smaller study populations, surrogate endpoints, and innovative statistical methods, when scientifically justified
Post-Market Phase
- Post-market data emphasis: In appropriate cases, FDA may agree to a greater reliance on post-market data collection versus extensive pre-market requirements, when scientifically justified
- Continued engagement: FDA maintains communication with sponsors during the post-market phase to address post-approval study requirements and other obligations
Important caveat: A 2025 JAMA Internal Medicine study found that breakthrough-designated devices had a mean FDA review time of 225.8 days for therapeutic devices and 243.3 days for high-risk devices. While 73.3% of high-risk breakthrough devices were reviewed within MDUFA statutory target timeframes, the review times can still be substantial — the designation does not guarantee a fast review.
Application Process: Step-by-Step
Step 1: Assess Eligibility
Before investing time in a designation request, carefully evaluate whether your device meets both Criterion 1 and at least one sub-criterion under Criterion 2. Review the FDA guidance document and consider requesting a pre-submission meeting to discuss eligibility informally.
Step 2: Prepare the Designation Request Package
The designation request should follow the format outlined in Appendix 1 of the FDA's Breakthrough Devices Program guidance. The package should include:
- Cover letter: Specifying that this is a Breakthrough Device Designation Request
- Device description: Detailed description of the device, its intended use, and proposed indications for use
- Proposed regulatory pathway: Identification of whether you intend to pursue 510(k), De Novo, or PMA, with rationale
- Criterion 1 justification: Documentation of the life-threatening or irreversibly debilitating nature of the targeted condition and evidence supporting a reasonable expectation that the device could provide more effective treatment or diagnosis
- Criterion 2 justification: Evidence supporting at least one of the four sub-criteria
- Preliminary evidence: Bench data, animal data, or early clinical data demonstrating technical feasibility and the potential for clinical success. Complete clinical data is not required, but sufficient evidence describing the device's capabilities must be included
- Development timeline: An overview of the anticipated development and submission timeline
- Comparison to standard of care: A clear explanation of current treatment options and how the device represents an improvement
Step 3: Submit via Q-Submission
Breakthrough Device Designation requests are submitted as a specific type of Q-Submission through the FDA electronic portal. There are two submission formats:
| Format | Details |
|---|---|
| eCopy | The recommended and easier method for BDD requests. Convert your submission documents to a zipped PDF and upload through the CDRH Customer Collaboration Portal (CCP) or mail physical media to the CDRH Document Control Center |
| eSTAR | An interactive PDF form that guides applicants through the submission process. While available, eCopy is generally preferred for BDD requests due to its flexibility |
For submissions to CDRH, use the CDRH Customer Collaboration Portal. For products regulated by CBER, submit through the FDA Electronic Submission Gateway.
There is no fee to submit a Breakthrough Device Designation request.
Step 4: FDA Review and Decision
| Milestone | Timeline |
|---|---|
| FDA acknowledges receipt | Shortly after submission |
| FDA may request additional information | Typically within 30 days |
| FDA decision (grant or deny) | Within 60 days of receipt |
The FDA decision is communicated in writing (via email). There is typically no meeting to discuss the decision. If additional information is needed, FDA will contact the sponsor via email within approximately 30 days.
Step 5: If Denied
If the designation request is denied, FDA provides a written justification explaining the rationale for its decision. This feedback can be valuable for refining your regulatory strategy. A new request may be submitted with additional information addressing the deficiencies outlined in the denial letter. You can also continue pursuing standard marketing authorization through the regular 510(k), De Novo, or PMA pathways — denial does not affect your ability to submit through standard channels.
Program Statistics and Data
Designations and Authorizations
The Breakthrough Devices Program has grown substantially since its inception. As of December 31, 2025, the most recent comprehensive data available:
| Metric | Count |
|---|---|
| Total Breakthrough Device designations granted | 1,246 |
| CDRH designations | 1,226 |
| CBER designations | 20 |
| Total marketing authorizations | 160+ |
| Approximate conversion rate (designation to authorization) | ~12-13% |
Designations by Fiscal Year
The number of designations has grown significantly over the program's lifetime:
| Fiscal Year | Designations Granted |
|---|---|
| 2015 (EAP included) | 11 |
| 2016 | 12 |
| 2017 | 19 |
| 2018 | 55 |
| 2019 | 110 |
| 2020 | 151 |
| 2021 | 206 |
| 2022 | 166 |
| 2023 | 145 |
| 2024 | 165 |
| 2025 (through Dec 31) | 136 |
Designations by Clinical Panel
The distribution of designations across clinical specialties reveals where innovation is concentrated:
| Clinical Panel | Designations |
|---|---|
| Cardiovascular | 243 |
| Neurology | 189 |
| Orthopedic | 161 |
| Gastroenterology & Urology | 108 |
| General & Plastic Surgery | 76 |
| Immunology | 49 |
| Pathology | 46 |
| Anesthesiology | 45 |
| Microbiology | 44 |
| Radiology | 43 |
| Clinical Chemistry | 42 |
| Molecular Genetics | 41 |
| Ophthalmology | 22 |
| Hematology | 21 |
| General Hospital | 13 |
| Ear, Nose & Throat | 10 |
| Physical Medicine | 10 |
| Dental | 5 |
| Obstetrics | 5 |
| Clinical Toxicology | 3 |
Authorization by Regulatory Pathway
Of the first 95 authorized breakthrough devices (as of end of 2023), the distribution across regulatory pathways was nearly even:
| Pathway | Count | Notes |
|---|---|---|
| 510(k) | 32 | Average review time: 152 days. While this may seem long compared to standard 510(k) review, it reflects the novelty and complexity of these devices. Standard 510(k)s requiring additional data average ~270 days |
| De Novo | 30 | Average review time: significantly faster than non-breakthrough De Novo requests |
| PMA | 31 | Review times vary; 73.3% of high-risk breakthrough devices reviewed within MDUFA goals |
| BLA/Other (CBER) | 2 | Device-led combination products reviewed by CBER |
What the Low Conversion Rate Means
With approximately 1,246 designations and 160+ authorizations, the conversion rate is around 12-13%. This does not indicate program failure. Most designated devices are still in development — the time from designation to market authorization can span several years. Some devices are discontinued during development due to clinical trial failures, funding challenges, or strategic business decisions, not regulatory barriers. Breakthrough designation makes the FDA pathway smoother, but it does not make device development itself easier.
How BDD Applies to Different Regulatory Pathways
510(k) Pathway
Breakthrough devices cleared through 510(k) must still demonstrate substantial equivalence to a predicate device. The designation benefits include priority queue placement and enhanced pre-submission interactions. However, the speed benefit for 510(k) is often modest — a 2025 analysis found that breakthrough 510(k) devices took approximately the same time as comparable non-breakthrough devices. The primary value for 510(k) devices comes from the interactive development support rather than review acceleration. Only about 0.1% of all 510(k) submissions are also breakthrough devices.
De Novo Pathway
The De Novo pathway is a natural fit for many breakthrough devices because it addresses novel devices without predicates. Breakthrough De Novo devices averaged approximately 75 days faster review times compared to non-breakthrough De Novo requests. The interactive communication and clinical protocol feedback available through the program are particularly valuable for De Novo devices, which require establishing new classification regulations and special controls.
PMA Pathway
High-risk breakthrough devices going through PMA benefit most from the program. Senior FDA management involvement, flexible study designs, and potential reliance on post-market data can significantly streamline what is normally the most resource-intensive regulatory pathway. Of the 34 high-risk therapeutic breakthrough devices studied in the 2025 JAMA Internal Medicine analysis, 73.3% were reviewed within MDUFA statutory target timeframes.
Device-Led Combination Products
Device-led combination products (where the primary mode of action is achieved by the device constituent part) are eligible for the Breakthrough Devices Program. These products are reviewed by either CDRH or CBER, depending on the product, with consultation from the Office of Combination Products. As of December 2025, CBER had granted 20 breakthrough designations.
Timeline and Process: From Designation to Authorization
Realistic Timeline Expectations
| Phase | Typical Duration |
|---|---|
| Preparation of BDD request | 1-3 months |
| FDA designation decision | 60 days (statutory) |
| Pre-submission meetings and development | 6-24+ months |
| Clinical trial conduct (if required) | 1-5+ years |
| Marketing submission preparation | 3-6 months |
| FDA review of marketing submission | 150-365+ days (varies by pathway) |
| Post-market study commitments | Ongoing |
Key Timeline Factors
- Device maturity: Submitting too early (concept stage) leads to denial. Submitting too late reduces the value of the development-phase benefits.
- Clinical evidence requirements: Novel devices often require new clinical data, which is typically the longest lead item.
- Regulatory pathway complexity: PMA devices generally take longer than De Novo or 510(k) devices.
- FDA staffing and workload: Recent reports indicate that FDA staff workloads have increased, which can affect review timelines regardless of breakthrough status.
Optimal Submission Timing
The best window for submitting a BDD request is during the device development phase after proof-of-concept has been established but before pivotal studies begin. At this point, preliminary evidence exists to support the designation criteria, and the FDA guidance received through the program can still meaningfully influence study design.
BDD vs. Other FDA Expedited Programs
The FDA has several expedited programs for medical devices. Understanding the differences is essential for choosing the right approach.
| Feature | Breakthrough Devices Program | Humanitarian Device Exemption (HDE) | Emergency Use Authorization (EUA) | De Novo Classification |
|---|---|---|---|---|
| Purpose | Expedite development and review of novel devices for serious conditions | Provide access to devices for rare conditions affecting ≤8,000 individuals/year | Enable access during declared emergencies | Classify novel low-to-moderate risk devices without predicates |
| Legal basis | FD&C Act Section 515B | FD&C Act Section 520(m) | FD&C Act Section 564 | FD&C Act Section 513(f)(2) |
| Eligibility | Devices meeting both designation criteria | Class III devices for rare conditions | Any medical product during declared emergency | Novel devices appropriate for Class I or II |
| Evidence standard | Same as standard pathway (reasonable assurance of safety and effectiveness) | Probable benefit (lower than PMA) | May be effective; benefits outweigh risks | Reasonable assurance of safety and effectiveness |
| Population restriction | None | ≤8,000 individuals/year | None (but emergency-specific) | None |
| Cost to apply | Free | User fees may apply | No fee during emergency | Standard user fees |
| Profit restriction | None | May apply unless specific exceptions | Not applicable | None |
| Duration | Permanent designation | Renewable 18-month approvals | Duration of emergency declaration | Permanent |
| Priority review | Yes | No (separate expedited pathway) | Expedited by nature | Not automatically, but can be combined with BDD |
| Marketing pathway | 510(k), De Novo, or PMA | HDE application (21 CFR 814 Subpart H) | EUA (temporary) | De Novo request |
When to Consider Each Pathway
- Breakthrough Devices Program: Best for novel devices targeting serious conditions with strong preliminary evidence and a clear development path to market authorization
- HDE: Appropriate when the target population is very small (fewer than 8,000 individuals per year) and the device is Class III, where the reduced evidence standard (probable benefit vs. reasonable assurance) is valuable
- EUA: Only available during declared public health emergencies; a temporary measure, not a path to permanent marketing authorization
- De Novo: The classification pathway itself; can be combined with BDD for novel, low-to-moderate risk devices meeting breakthrough criteria
Health Equity and Expanded Eligibility
The 2023 guidance update represents a significant philosophical shift in how the FDA evaluates breakthrough device eligibility, explicitly incorporating health equity considerations.
What FDA Now Considers
When assessing BDD eligibility, FDA may evaluate:
- Disparity-reducing technologies: Devices with features specifically designed to address healthcare disparities in populations defined by race, ethnicity, sex, age, disability, socioeconomic status, or geographic location
- Population-specific pathophysiology: Devices designed to account for differences in disease presentation, progression, or treatment response across demographic groups
- Accessibility improvements: Devices that can be used effectively in settings where care is currently limited, including rural areas, community health centers, or home-based care environments
- Reduced barriers to adherence: Devices that make it easier for patients to follow prescribed treatment regimens, particularly in underserved populations
Practical Implications for Applicants
If your device addresses health equity concerns, you should explicitly discuss this in your designation request. Document how the device targets populations that experience disparities, include any preliminary data showing differential effectiveness or access improvements, and explain how the device features are tailored to address the specific barriers those populations face.
Non-Addictive Products
Under the SUPPORT Act mandate, devices that serve as non-addictive alternatives for treating pain or addiction are now explicitly eligible for consideration. This includes neuromodulation devices, physical therapy devices, digital therapeutics for substance use disorders, and similar technologies that could reduce reliance on opioid medications.
Common Mistakes in BDD Applications
Understanding why designation requests fail can dramatically improve your chances of success.
1. Submitting Too Early
Many manufacturers submit before the device has progressed beyond the concept stage. FDA expects to see evidence that the device can function as intended. If you have no bench data, no animal data, and no engineering prototypes, the request is premature. The FDA guidance explicitly states that even if the design clearly satisfies the criteria, the request may be declined if data demonstrating the device's ability to achieve its proposed performance characteristics are not included.
2. Weak Documentation of Unmet Medical Need
Generic statements about "improving patient outcomes" are insufficient. Strong applications include specific data on disease prevalence, mortality rates, current treatment limitations, and quantified gaps in the standard of care. Cite peer-reviewed literature and quantify the patient population affected.
3. Focusing on Technology Rather Than Clinical Benefit
A common error is emphasizing how innovative the technology is without clearly connecting it to improved clinical outcomes. The FDA evaluates whether the device provides more effective treatment or diagnosis, not whether the technology is novel for its own sake. Frame your argument around the clinical benefit to patients.
4. Inadequate Comparison to Standard of Care
Your application must clearly articulate what the current standard of care is in the United States and how your device represents a meaningful improvement. Failing to accurately describe existing alternatives or overstating their limitations weakens your case.
5. Treating the BDD Request as a Pre-Submission
A BDD request is not an opportunity to ask FDA questions or seek general regulatory advice. It is a formal designation request with a specific purpose and format. Mixing in questions about study design or regulatory strategy can dilute the clarity of your designation argument.
6. Requesting Designation for Multiple Devices or Indications
Each BDD request should cover only one proposed device and one intended use. Submitting a request that covers multiple devices or broad, vague indications confuses the evaluation and increases the likelihood of denial.
7. Submitting After the Marketing Application
This is a disqualifying error. The BDD request must be received before the marketing submission. If you submit a 510(k), De Novo, or PMA and then try to request BDD, FDA will not review the request.
8. Vague or Overly Broad Indications
Proposed indications that are too broad or vague make it difficult for FDA to evaluate whether the designation criteria are met. Be specific about the target condition, patient population, and clinical setting.
Case Studies and Examples of Authorized Breakthrough Devices
The following examples illustrate the range of devices that have received both Breakthrough Device Designation and marketing authorization.
Cardiovascular
- Edwards SAPIEN 3 Transcatheter Heart Valve: A transcatheter-delivered valve that eliminated the need for open-heart surgery in high-risk patients, representing breakthrough technology (Criterion 2A)
- Abbott Aveir DR Leadless System: A leadless dual-chamber pacemaker system offering significant advantages over traditional transvenous pacing systems
- Medtronic PulseSelect Pulsed Field Ablation System: A novel tissue-selective ablation approach for atrial fibrillation that avoids damage to surrounding structures
- TriClip G4 System: A transcatheter tricuspid valve repair device addressing an underserved patient population with severe tricuspid regurgitation
- Esprit BTK Everolimus Eluting Resorbable Scaffold: A bioresorbable scaffold for below-the-knee arterial disease, addressing a condition with limited treatment options
Neurology
- Ceribell Status Epilepticus Monitor and Delirium Monitor: Rapid bedside EEG devices enabling earlier diagnosis of neurological emergencies in time-critical settings
- EBR Systems WISE CRT System: Wireless cardiac resynchronization technology eliminating the need for transvenous leads, reducing infection risk
- Vercise Deep Brain Stimulation Systems: Advanced DBS technology for Parkinson's disease and other movement disorders with improved targeting capabilities
- Flow Neuroscience FL-100: A transcranial magnetic stimulation device for depression, representing a non-pharmacological treatment approach
Orthopedic
- MISHA Knee System: A medical implant designed to treat knee osteoarthritis without bone removal, preserving anatomy for future interventions
- restor3D Tidal Fusion Cage System: 3D-printed patient-specific spinal fusion implants
- Companion Spine DIAM Spinal Stabilization System: A non-fusion motion-preserving device for spinal stenosis
- Active Protective Technologies Tango Belt: A wearable hip protection device that deploys airbags to prevent fall-related hip fractures
Diagnostics
- Fujirebio LumipULSE pTau217/Beta-Amyloid 1-42 Plasma Ratio: The first blood test cleared for aiding in the diagnosis of Alzheimer's disease, representing a significant diagnostic advancement
- Roche Elecsys sFlt-1 and PlGF: Biomarker tests for risk assessment of preeclampsia, a leading cause of maternal mortality
- ArteraAI Prostate: An AI-powered diagnostic tool for personalized prostate cancer treatment planning
- Inflammatory TRIVERITY: A rapid host-response test for distinguishing bacterial vs. viral infections
Digital Health and AI
- Click Therapeutics CT-132: A prescription digital therapeutic authorized through the De Novo pathway
- Annalise Enterprise CTB Triage-OH: AI-based triage software for CT brain imaging
- Intuitive Surgical da Vinci X/XI Systems: Advanced robotic surgical systems with enhanced capabilities
Post-Designation Obligations
Receiving Breakthrough Device Designation is the beginning, not the end, of an enhanced regulatory engagement.
Active Participation Requirements
The FDA expects designated sponsors to actively participate in the program, including:
- Responding to FDA communications in a timely manner
- Attending scheduled meetings and providing requested materials
- Engaging in iterative discussions about clinical protocols and development plans
- Maintaining development progress toward marketing submission
If a sponsor is consistently unresponsive or fails to engage with FDA's communications, the agency may rescind the designation.
When Designation May Be Revoked
FDA may revoke Breakthrough Device Designation if:
- New information demonstrates the device no longer meets the designation criteria
- The sponsor is not actively pursuing marketing authorization
- The sponsor is not engaging with the FDA's communications
- The sponsor requests withdrawal of the designation
Designation Does Not Expire
Breakthrough Device Designation does not have an expiration date. It remains in effect until the device receives marketing authorization, the designation is revoked, or the sponsor withdraws from the program.
Post-Market Study Requirements
Breakthrough-designated devices may have post-market study commitments. A 2025 analysis found that FDA required 46 post-market studies for 30 breakthrough-designated devices (40% of therapeutic devices studied). Notably, 41.3% of those studies reported delays, which underscores the importance of planning and adequately resourcing post-market commitments.
Tips for a Successful BDD Application
Before You Submit
Read the guidance thoroughly: The FDA's Breakthrough Devices Program guidance (updated September 2023) provides detailed instructions on the content and format of designation requests, including Appendix 1 which outlines the expected request structure.
Gather preliminary evidence: Even if clinical data is limited, assemble bench testing results, animal study data, computational modeling results, or published literature that supports both technical feasibility and the potential for clinical benefit.
Document the standard of care comprehensively: Include specific citations from clinical guidelines, peer-reviewed literature, and FDA databases. Quantify the limitations of current treatments.
Be specific about your target population and indication: Vague or overly broad indications weaken your application. Define the exact disease condition, patient population, and clinical setting.
Consider a pre-submission meeting first: If you are uncertain about eligibility, consider requesting a pre-submission meeting to discuss your device informally before filing the formal BDD request.
Preparing the Request
Follow the Appendix 1 format: Structure your request according to the FDA's recommended format. This makes it easier for reviewers to find the information they need.
Be concise but complete: The guidance advises that the document should be "as concise as possible, while providing evidence the two criteria are met." Avoid unnecessary background information that does not directly support the designation criteria.
Clearly identify which Criterion 2 sub-criterion you are meeting: Explicitly state which of the four sub-criteria (A, B, C, or D) your device satisfies and provide focused evidence for that specific sub-criterion.
Include a development timeline: Show FDA that you have a realistic plan for pursuing marketing authorization in the near future. The device should be sufficiently mature in design and validation.
Explicitly address health equity if applicable: If your device addresses healthcare disparities or improves accessibility, document this thoroughly. The 2023 guidance update makes this a legitimate basis for designation.
After Designation
Develop a communication plan: Establish regular touchpoints with your FDA review team. Take advantage of sprint discussions and interactive communication opportunities.
Be prepared for iterative clinical protocol development: The FDA expects to work with you on refining your clinical study design. Come to meetings prepared with options and questions, not just proposals.
Maintain momentum: Long gaps in communication can signal a lack of commitment and may result in designation review or revocation.
Frequently Asked Questions
1. Does Breakthrough Device Designation guarantee FDA approval or clearance?
No. Breakthrough Device Designation does not alter the statutory standards for marketing authorization. Designated devices must still meet the same safety and effectiveness requirements as non-designated devices. The designation provides process efficiencies — priority review, enhanced communication, flexible study designs — but does not lower the evidence bar.
2. Do I need completed clinical studies to apply for BDD?
No. Complete clinical data is not required for the designation request. The FDA expects to see evidence supporting a reasonable expectation that the device could provide more effective treatment or diagnosis. This can include bench data, animal data, preliminary clinical data, or published literature. However, if no data demonstrating the device's capabilities is included, the request is likely to be denied regardless of how well the criteria are argued.
3. Can a 510(k) device receive Breakthrough Device Designation?
Yes. While most breakthrough devices go through De Novo or PMA pathways, 32 of the first 95 authorized breakthrough devices were cleared through 510(k). The device must still identify a predicate and demonstrate substantial equivalence, but the breakthrough designation provides enhanced FDA interaction during development. Note that only about 0.1% of all 510(k) submissions are also breakthrough devices.
4. What happens if a competing device gets authorized while I have BDD?
FDA will not revoke your Breakthrough Device designation solely because another device with the same intended use has received marketing authorization. Your designation and its benefits remain in effect. However, if you are applying for BDD after a competing device has been authorized, you will need to demonstrate how your device is different or superior to the newly available alternative.
5. Is there a fee to submit a Breakthrough Device Designation request?
No. There is no fee to submit a BDD request. The standard user fees that apply to 510(k), De Novo, and PMA submissions still apply when you submit the actual marketing application, but the designation request itself is free.
6. Can I resubmit if my BDD request is denied?
Yes. If your request is denied, FDA provides written justification. You may submit a new request with additional information addressing the specific deficiencies identified in the denial letter. You can also pursue standard marketing authorization through the regular pathway without breakthrough designation.
7. Does BDD help with Medicare reimbursement?
The reimbursement landscape for breakthrough devices has evolved. The CMS Transitional Coverage for Emerging Technologies (TCET) pathway is available but limited to approximately 5 breakthrough devices per year. Previous proposals for automatic Medicare coverage for breakthrough devices have not been implemented. Reimbursement strategy should be developed independently from the regulatory strategy, though breakthrough designation can support coverage arguments.
8. Can foreign manufacturers apply for BDD?
Yes. Any sponsor, regardless of location, can submit a Breakthrough Device Designation request. Foreign manufacturers must have a designated U.S. Agent and comply with all applicable registration and listing requirements.
9. How does BDD differ from the Safer Technologies Program (STeP)?
The Safer Technologies Program (STeP) is for devices that are expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious than those targeted by the Breakthrough Devices Program. BDD requires life-threatening or irreversibly debilitating conditions, while STeP targets conditions associated with mild to moderate morbidity where there is a clear opportunity for safety improvement.
10. Can I request BDD for a device that is an improvement to an already marketed device?
Yes, if the improved device targets the same or a different life-threatening or irreversibly debilitating condition and meets the designation criteria. The improvement must represent a significant clinical advantage, not merely an incremental engineering change. A device modified to address an unanticipated serious failure in an approved device may also qualify under Criterion 2(D).
11. How long does the entire process take from BDD to market authorization?
There is no single answer, as it depends on the device complexity, regulatory pathway, clinical evidence requirements, and development timeline. Some devices have received authorization within 1-2 years of designation, while others have taken 5+ years. The clinical trial phase is typically the longest component. Plan for 2-5 years from designation to authorization for most novel devices.
12. Does FDA proactively identify potential breakthrough devices?
Yes. FDA may identify devices that could be good candidates for the Breakthrough Devices Program and recommend that sponsors consider applying. This can occur during pre-submission meetings, IDE reviews, or other interactions with the agency. However, the sponsor must still submit a formal designation request — FDA cannot grant BDD without a formal request from the sponsor.
13. What is the difference between BDD and Priority Review?
Priority Review for medical devices was an earlier program that has been subsumed into the Breakthrough Devices Program. Breakthrough Device Designation now includes priority review as one of its benefits, along with many additional advantages such as interactive communication, sprint discussions, and senior management involvement that were not part of the original Priority Review program.
14. Are digital therapeutics eligible for BDD?
Yes. Several digital therapeutics have received Breakthrough Device Designation, including Click Therapeutics CT-132 (authorized through De Novo in April 2025) and Swing Therapeutics Stanza (authorized through De Novo in May 2023). Digital therapeutics targeting serious conditions that meet the designation criteria are eligible.
15. What role does patient preference information play in BDD requests?
Sponsors may submit patient preference information to support their BDD request. FDA guidances on "Patient Preference Information" and "Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments" provide frameworks for incorporating this data. Patient preference data can strengthen the argument that a device provides more effective treatment, particularly when it demonstrates that patients value outcomes that differ from traditional clinical endpoints.
Key Takeaways
The FDA Breakthrough Devices Program is one of the most impactful regulatory tools available to medical device innovators targeting serious conditions. The key points to remember:
- Eligibility requires both criteria: The device must target a life-threatening or irreversibly debilitating condition AND meet at least one of four secondary criteria.
- Designation is not approval: The same evidence standards apply. BDD provides process benefits, not a lower bar.
- Timing matters: Submit after proof-of-concept but before pivotal studies for maximum benefit.
- Health equity is now a factor: The 2023 guidance update expanded eligibility to devices addressing healthcare disparities.
- The conversion rate is low but improving: Approximately 12-13% of designated devices have reached the market so far, but many are still in active development.
- Benefits are real but variable: Review acceleration is most pronounced for PMA and De Novo pathways; 510(k) benefits are primarily in enhanced development support.
- Active engagement is expected: FDA expects sponsors to participate fully in the interactive elements of the program.
For the latest statistics and the full list of authorized breakthrough devices, refer to the FDA's Breakthrough Devices Program page on fda.gov.
Related Guides
- FDA Pre-Submission (Q-Submission) Guide — How to prepare and submit a Pre-Sub, including breakthrough designation requests.
- FDA De Novo Classification Guide — The alternative pathway for novel low-to-moderate risk devices without a predicate.
- 510(k) Submission Guide — Complete walkthrough of the 510(k) process from predicate selection to FDA clearance.
- AI/ML Medical Device Regulatory Guide — Regulatory frameworks for artificial intelligence and machine learning-based devices.
- Medical Device Clinical Trials & IDE Guide — Planning and executing clinical studies under an Investigational Device Exemption.