From Concept to Market: How the FDA’s Breakthrough Device Designation Works
The Breakthrough Devices Program by the FDA is designed to expedite the review and development of medical devices and in vitro diagnostics (IVD) that may provide a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
The goal of BDD is to provide expedited patient access to novel products by accelerating their development, assessment, and review while also preserving the FDA’s statutory standards for premarket approval (PMA), 510(k) clearance, and De Novo marketing authorization.
The program is voluntary, and the FDA provides a written decision (granted/denied) via email.
Breakthrough Devices Program Principles
To qualify for the FDA’s BDD, a device must meet Criterion 1 (provide a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating disease or condition) and one of the following Criterion 2 options:
- The device represents breakthrough technology
- No approved or cleared alternatives exist
- The device offers significant advantages over existing approved or cleared alternatives
- Device availability is in the best interest of patients
Key Elements of the Request Process
Purpose of Request: Sponsors submit a Breakthrough Device designation request to enter the FDA’s Breakthrough Devices Program and receive a decision within 60 days.
Content of Request: Sponsors must clearly specify the proposed indications for use, potentially focusing on specific subgroups within a larger disease population.
Interactive and Timely Communication with Sponsors: The FDA ensures ongoing interaction with sponsors during the development and review process.
Consultation with Experts: In case of novel scientific issues, FDA may consult with external experts or Advisory Committees, disclosing topics and decisions to the sponsor.
Timing of Request: A designation request can be made at any point before submitting a premarket approval application, a 510(k) notification, or a petition for reclassification under specified sections of the FD&C Act.
Changes to the Breakthrough Guidance from 2018 to 2023
The breakthrough Device program may now apply to:
Health Disparity Considerations – The FDA now considers technologies and device features that help address health and healthcare disparities and promote health equity when determining BDD eligibility.
Non-Addictive Pain and Addiction Treatment Technologies – The program now includes non-addictive products or methods for treating pain or addiction.
Refinement of the “More Effective” Criterion – The FDA considers the totality of available information, considering its clinically meaningful impact, as well as its potential benefits and risks, to determine if a device qualifies as “more effective.”
Transparency in Advisory Committee Consultations – A new paragraph explains the extent to which the FDA discloses information related to a sponsor’s Breakthrough Designation when consulting an Advisory Committee.
Key Advantages of BDD
Sprint discussions
Sponsors can engage in “sprint” discussions with the FDA, allowing for faster resolution of issues (typically around 45 days) that might otherwise delay development.
These discussions are flexible, allowing sponsors to adjust the schedule and topics as needed.
Priority Review
Devices with BDD receive priority review, meaning their submissions are moved to the top of the queue and get extra resources for faster review. However, because these devices often involve new scientific challenges, the review may still take longer than for other devices.
Reimbursement
Transitional Coverage for Emerging Technologies (TCET) Pathway: The Centers for Medicare & Medicaid Services (CMS) finalized the notice in August 2024 outlining a Medicare coverage pathway to achieve more timely and predictable access to certain new medical technologies. BDD facilitates the application for this payment.
Eligibility for New Technology Add-On Payment (NTAP) pathway: BDD products that receive FDA marketing authorization qualify as ‘new’ and are eligible for the NTAP pathway, which provides additional reimbursement for new technologies.
Challenges in BDD Timing and Criteria
One common challenge with Breakthrough Device submissions is that some manufacturers submit too early, often before the device has moved beyond the concept stage. For a successful Breakthrough Device submission, it’s crucial to understand and meet the FDA’s criteria.
Device and Data Requirements (Criterion 1)
To meet Criterion 1 (to provide a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating disease or condition), manufacturers must have a working device prototype and data demonstrating both technical feasibility and clinical success. Submitting prematurely—without this foundational evidence—often results in delays or denials. The FDA expects a device to be past the concept phase and evaluates the totality of information to determine its functionality and benefit.
This data typically includes proof-of-concept studies, early-stage clinical or analytical performance data, and technical assessments that show the device functions as expected.
Consideration of Patient Choice (Criterion 2)
Manufacturers can include patient choice as a factor particularly if the device offers a unique advantage or choice for patients such as reducing invasiveness or increasing accessibility. However, patient choice alone is typically not sufficient; it should be paired with demonstrated clinical benefits.
An Opportunity to Accelerate Your Path to Market
The Breakthrough Devices Program is a valuable opportunity for IVD manufacturers to accelerate their path to market for transformative diagnostic tools. Understanding the program’s requirements enables manufacturers to navigate the process effectively, bringing life-changing innovations to patients sooner.
If you are considering this pathway for your IVD, engage with us at MDC Associates early. We can help you strategize and align on clinical and analytical study requirements, leveraging our expertise to maximize your success.
Why MDC Associates?
- Accelerated Path to Market: Over 35 years of IVD expertise across a broad range of technologies and applications, guiding you through regulatory and clinical processes efficiently.
- Regulatory Expertise with Continuous FDA Engagement: Our established, positive relationship with the FDA helps you navigate submissions like Pre-subs, 510(k), De Novo, and PMAs smoothly.
- Practical Quality Expertise: We help you achieve your quality objectives without overwhelming your team with too much too soon. From eQMS to MDSAP and ISO audits, get expert advice and hands-on support.
- Extensive Clinical Site Network: Access a trusted network experienced in supporting high-complexity assays, CLIA-waived tests, and OTC diagnostics, providing fast and reliable performance validation.
- Your Trusted IVD CRO: Beyond strategy, we work as part of your team to execute critical steps in regulatory submissions, clinical trials, and quality systems compliance.
