Breakthrough Devices Program: Expedited Development and Review Process for Novel Medical Devices
This guidance describes the Breakthrough Devices Program, a voluntary program for certain medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program aims to expedite development, assessment and review of these devices while preserving statutory standards for marketing authorization.
What You Need to Know? 👇
What is the FDA Breakthrough Devices Program and who is eligible?
The Breakthrough Devices Program is a voluntary FDA program for medical devices and device-led combination products that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Eligible devices must meet specific criteria and be subject to PMA, 510(k), or De Novo review pathways.
How long does FDA take to review a Breakthrough Device designation request?
FDA issues a grant or denial decision within 60 calendar days of receiving a Breakthrough Device designation request. The Agency typically interacts with sponsors by Day 30 regarding any additional information needed to inform the designation decision.
What are the key benefits of receiving Breakthrough Device designation?
Designated devices receive priority review, interactive and timely communication with FDA, potential for expedited manufacturing inspections, access to special program features like sprint discussions and Data Development Plans, and senior management engagement throughout the review process.
Can multiple devices with the same intended use receive Breakthrough designation?
Yes, multiple devices with the same intended use can receive Breakthrough designation simultaneously. However, once a Breakthrough Device is approved or cleared, additional devices with the same intended use will only be designated if they still meet the criteria considering the first device’s market availability.
What is a “sprint discussion” in the Breakthrough Devices Program?
A sprint discussion is an intensive, time-limited interaction (typically 45 days) between FDA and sponsors to reach mutual agreement on a specific topic. It involves a defined interaction schedule, single topic focus, and clear documentation of conclusions to expedite device development.
How does the program address health disparities and promote health equity?
The program considers technologies that help reduce health and healthcare disparities by providing more effective treatment or diagnosis in populations experiencing disparities. This includes devices designed to address characteristic differences in pathophysiology, clinical features, or treatment responses across diverse populations.
What You Need to Do 👇
Recommended Actions
- Submit Breakthrough Device designation request as Q-Submission before marketing application
- Clearly indicate proposed indications for use and rationale for meeting designation criteria
- Consider developing Data Development Plan early after designation to outline testing strategy
- Utilize sprint discussions for timely resolution of novel issues
- Consider Clinical Protocol Agreement for binding commitments on study protocols
- Maintain regular communication with FDA review team through status updates
- Plan manufacturing approach early, especially for PMAs
- Document all interactions and agreements with FDA clearly
- Consider postmarket data collection strategies to support expedited development
- Engage senior management early when facing unresolved issues
Key Considerations
Clinical testing
- Efficient and flexible clinical study design allowed when scientifically appropriate
- Can use prespecified endpoints regarding minimum clinically meaningful effect
- Can use intermediate and surrogate endpoints with supporting evidence
- Can use composite endpoints with rationale for meaningful effect size
- Can use adaptive study designs
Non-clinical testing
- Early consideration of non-clinical testing requirements recommended
- Testing approach and timing relative to clinical studies should be discussed in Data Development Plan
- Some non-clinical testing may be deferred with appropriate subject protections
Safety
- Must still meet statutory standards for safety and effectiveness
- Greater uncertainty in benefit-risk profile may be acceptable if balanced by other factors
- Postmarket data collection can be used to facilitate expedited development when appropriate
Other considerations
- Interactive and timely communication between FDA and sponsor
- Priority review status granted
- Senior management engagement in review process
- Manufacturing considerations may be streamlined for PMAs
- Regular status updates between FDA and sponsor available
- Data Development Plan can be used to outline data collection expectations
- Clinical Protocol Agreement available with binding commitments
Relevant Guidances đź”—
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
- Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
- Benefit-Risk Determinations for Medical Device Premarket Review
Related references and norms đź“‚
- ISO 14971: Medical devices – Application of risk management to medical devices
- IEC 60601-1-2: Medical electrical equipment - Electromagnetic compatibility
- ISO 10993: Biological evaluation of medical devices