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.
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
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- 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
- 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
Original guidance
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