FDA Breakthrough Device Designation: Accelerating Innovation in Medical Technology
The medical device industry is constantly evolving, with transformative technologies on the horizon. However, market entry can be lengthy and complex. The FDA's Breakthrough Devices Program offers a faster pathway for genuinely innovative devices that address critical unmet medical needs.
What Is Breakthrough Device Designation?
Established under the 21st Century Cures Act and codified in section 515B of the FD&C Act, the Breakthrough Devices Program is a voluntary pathway for select medical devices and device-led combination products. It applies to devices seeking PMA, 510(k), or De Novo marketing authorization and is intended to speed development, assessment, and review while ensuring safety and effectiveness [1].
Eligibility Criteria
To qualify for Breakthrough Device designation, a device must satisfy:
First Criterion
Whether a Device Provides for “More Effective” Treatment or Diagnosis
Whether a Disease or Condition is “Life-Threatening”
Whether a Disease or Condition is “Irreversibly Debilitating”
Second Criterion
Device Represents Breakthrough Technology
No Approved or Cleared Alternatives Exist
Device Offers Significant Advantages over Existing Approved or Cleared Alternatives
Device Availability is in the Best Interest of Patients
The FDA also considers whether technologies may help address health and healthcare disparities and promote health equity. Additionally, certain non-addictive medical products for the treatment of pain or addiction may qualify, per the SUPPORT Act amendments.
Key Benefits of Designation
Expedited Review
Priority review at pre-submission and marketing stages
Enhanced developer-FDA communication and feedback loops
Senior leadership engagement within FDA review teams
FDA Collaboration
Interactive, frequent discussions on study design
Potential for innovative clinical trial approaches, adaptive endpoints, and flexible data strategies, including postmarket data use where appropriate
Market and Strategic Advantage
Earlier patient access and competitive differentiation
Enhanced investor appeal
Favorable perception among payers and reimbursement entities
Application Process Overview
Preparation Phase
Compile:
Device description and intended use
Preliminary clinical or analytical evidence demonstrating breakthrough potential
Unmet need justification and alignment with FDA criteria
Submission Requirements
Detailed device description
Indications for Use
Regulatory History
Justification of which criterion is met
Development plan and regulatory strategy
FDA Review Timeline
FDA aims to respond within 60 calendar days
Classification: completeness check, criteria assessment, feedback requests, and decision issuance
Post-Designation Expectations
Ongoing Communication
Schedule frequent Q-Submission (Q-Sub) or pre-submission meetings
Provide periodic updates as clinical evidence accumulates
Adhere to agreed development milestones and timelines
Compliance and Quality Systems
Maintain a robust quality management system (QMS) and documentation
Track and document all FDA interactions
Report significant changes, adverse events, or emerging safety issues promptly
Illustrative Examples
Devices that have benefited from designation include:
AI-powered diagnostic tools, such as systems detecting diabetic retinopathy, breast cancer, or cardiovascular conditions, are demonstrating improved accuracy, earlier detection, or broader access
Innovative cardiac devices, including minimally invasive valve replacement systems, advanced monitoring tools, and arrhythmia treatment devices
Targeted cancer technologies, such as precision imaging, delivery systems, and planning tools that facilitate earlier or more personalized interventions
(Note: specific device examples are illustrative; publicly available case studies exist.)
Strategic Considerations
Is Breakthrough Designation Right for Your Device?
Does your device truly target an unmet need in a serious disease area?
Is there sufficient preliminary evidence to support a breakthrough designation?
Is your team ready for intensive FDA interaction?
Will the designation realistically shorten your overall path to market?
Preparation Strategies
Begin planning early
Design clinical protocols with breakthrough criteria in mind
Engage with FDA reviewers early via Q-Subs
Consider statistical and regulatory consultants experienced in the Breakthrough pathway
Future Trends
The FDA continues to refine program policies, with emphasis on:
Digital health and software-based medical devices
Devices tailored for precision or personalized medicine
Innovations addressing health equity and rare diseases
Streamlining eligibility and feedback processes [1]
Conclusion
The FDA Breakthrough Devices Program remains a powerful tool for accelerating the path to market for truly transformative medical devices. By offering expedited review and deeper FDA collaboration—while maintaining high standards for safety and effectiveness—designated devices have the potential to reach patients faster and with greater impact. Careful planning, strong preliminary evidence, and strategic FDA engagement are key to leveraging the program effectively.
Footnotes:
[1] FDA Guidance: Breakthrough Devices Program (Sept 2023): https://www.fda.gov/media/162413/download
[2] Report to Congress BREAKTHROUGH DEVICES PROGRAM: https://www.fda.gov/media/124747/download