Breakthrough Device is an FDA program designation for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Complete Guide to Breakthrough Device
The FDA Breakthrough Devices Program is designed to expedite the development, assessment, and review of innovative medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. This program aims to provide patients with timely access to breakthrough technologies that may significantly improve existing treatment options.
Designation Criteria:
To qualify for Breakthrough Device designation, a device must meet two key requirements:
- 1Address life-threatening or irreversibly debilitating conditions - The device must be intended to treat or diagnose a disease or condition that:
- 1Demonstrate breakthrough technology - The device must meet at least one of these criteria:
Breakthrough advantages may include improved clinical outcomes, better safety profile, reduced complications, earlier diagnosis, or improved patient compliance.
Program Benefits:
1. Interactive Review and Communication
- More frequent and collaborative interactions with FDA review staff
- Opportunity to discuss evidence needed to support approval/clearance
- Real-time feedback on study protocols and endpoints
- Helps sponsors avoid costly pivots late in development
2. Priority Review
- Assigned to senior FDA management for oversight
- Resources prioritized for timely review
- Goal to complete review as efficiently as possible
- Dedicated case manager assigned to facilitate communication
3. Sprint Discussions
- Planned structured interactions throughout device development
- FDA commits to timely responses (typically within weeks)
- Covers topics like clinical study design, nonclinical testing, and regulatory strategy
- More proactive than standard Q-Submission process
4. Manufacturing and Testing Guidance
- Early collaboration on manufacturing and testing protocols
- Opportunity to discuss acceptance criteria before full validation
- Potential for staged submissions and modular review
Application Process:
1. Submission Requirements
A Breakthrough Device designation request should include:
- Description of the device and its proposed use
- Clinical condition the device will treat or diagnose
- Explanation of how the device addresses an unmet medical need
- Evidence demonstrating breakthrough technology criteria
- Preliminary clinical or nonclinical data (if available)
- Proposed development and regulatory pathway
2. FDA Review Timeline
- FDA has 60 calendar days to grant or deny the request
- If additional information is needed, the clock stops until provided
- FDA will provide written feedback on the decision
- Sponsors can request a meeting to discuss the decision
3. Post-Designation Requirements
- Maintain ongoing communication with FDA
- Update FDA on significant developments or changes
- Participate in scheduled sprint discussions
- Submit required data and documentation on agreed timelines
Comparison to Breakthrough Therapy Designation for Drugs:
The Breakthrough Devices Program is similar to the FDA's Breakthrough Therapy designation for drugs, but with important differences:
Similarities:
- Both aim to expedite development and review of innovative therapies
- Both require treating serious or life-threatening conditions
- Both provide enhanced FDA interaction and guidance
- Both prioritize agency resources for review
Differences:
- Evidence threshold: Breakthrough Therapy requires preliminary clinical evidence of substantial improvement. Breakthrough Device does not require clinical data at designation, though supporting evidence strengthens the request
- Regulatory pathway: Devices may use 510(k), De Novo, or PMA pathways. Drugs use NDA or BLA
- Post-market requirements: Devices may have post-approval studies or conditional approval provisions more readily available
Strategic Considerations:
When to Apply:
- Early in development to maximize program benefits
- When you have preliminary evidence supporting breakthrough claims
- Before finalizing clinical study protocols to benefit from FDA feedback
- As part of pre-submission strategy planning
Success Factors:
- Clear demonstration of unmet medical need
- Strong preliminary evidence of device effectiveness
- Well-defined regulatory pathway and development plan
- Commitment to ongoing FDA collaboration
- Adequate resources to maintain accelerated timelines
Impact on Market Access:
Breakthrough Device designation does not guarantee approval or clearance, but it can significantly accelerate the pathway to market. The enhanced FDA interaction helps sponsors:
- Design more efficient clinical studies
- Avoid unnecessary testing or data collection
- Reduce overall development timelines
- Improve likelihood of successful regulatory submission
- Potentially gain competitive advantage through faster market entry
Examples of Breakthrough Devices:
- AI-powered diagnostic imaging systems for early cancer detection
- Novel heart valves for transcatheter replacement
- Closed-loop insulin delivery systems for diabetes management
- Brain-computer interfaces for paralysis patients
- Advanced imaging systems for surgical guidance
Related Terms
More Submission Types
View allA premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device.
A streamlined FDA 510(k) submission pathway that relies on FDA guidance documents, special controls, or recognized consensus standards to demonstrate substantial equivalence.
An FDA regulatory pathway for novel, low-to-moderate risk medical devices that have no predicate device for 510(k) comparison.
An FDA emergency authorization pathway that allows unapproved medical products to be used during public health emergencies when no adequate approved alternatives exist.
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