Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
This guidance introduces the Safer Technologies Program (STeP), a voluntary program for medical devices and device-led combination products that are expected to significantly improve safety compared to currently available treatments or diagnostics. The program focuses on devices targeting conditions less serious than those eligible for the Breakthrough Devices Program, while being subject to PMA, De Novo, or 510(k) review pathways.
What You Need to Know? 👇
What is the FDA’s Safer Technologies Program (STeP) for medical devices?
STeP is a voluntary FDA program for medical devices and device-led combination products that significantly improve safety of treatments/diagnostics for non-life-threatening conditions. It expedites development and review while maintaining regulatory standards.
Which devices are eligible for the Safer Technologies Program?
Devices must be subject to PMA, De Novo, or 510(k) pathways, not eligible for Breakthrough designation due to less serious conditions, and reasonably expected to significantly improve safety through substantial innovations.
How does STeP differ from the FDA’s Breakthrough Devices Program?
STeP targets devices treating less serious, non-life-threatening conditions while Breakthrough focuses on life-threatening/irreversibly debilitating diseases. STeP offers similar expedited features but with lower priority when resources are limited.
What are the four safety improvement categories for STeP eligibility?
The categories are: reduction in known serious adverse events, reduction in known device failure modes, reduction in known use-related hazards/errors, and improvement in safety of another device/intervention.
How long does FDA take to review STeP inclusion requests?
FDA intends to include or deny inclusion within 60 calendar days of receiving the Q-submission request. The Agency may interact with sponsors within 30 days for additional information needs.
What feedback mechanisms are available for devices included in STeP?
STeP devices can access sprint discussions for timely issue resolution, Data Development Plan reviews for lifecycle planning, traditional pre-submissions, and regular status updates with expedited timelines when resources permit.
What You Need to Do 👇
Recommended Actions
- Evaluate eligibility for STeP program based on general and specific factors
- Submit Q-submission request for program inclusion before marketing submission
- Prepare comprehensive device description and safety improvement justification
- Plan early engagement with FDA through available mechanisms (Sprint, DDP)
- Develop clear safety improvement metrics and evaluation strategy
- Consider both pre and post-market data collection strategies
- Prepare for interactive review process with FDA
- Establish regular status update schedule with FDA
- Document all safety innovations and their expected benefits
- Plan manufacturing quality system compliance for PMA submissions
Key Considerations
Clinical testing
- Clinical data may be needed to support safety improvement claims
- Efficient and flexible clinical study designs may be considered
- Real-world data sources may be used to support proposed indications
Non-clinical testing
- Early discussion of non-clinical testing requirements is encouraged
- Testing should be planned early in development process
- Proposals should be discussed with FDA
Human Factors
- Use-related hazards and errors should be addressed through device design
- Focus on reducing use-related hazards associated with design/operational features
- Not focused on labeling-related hazards
Labelling
- Should include specific claims related to safety improvement if planned
- Must meet applicable statutory standards
- Should clearly describe intended use and safety benefits
Safety
- Must demonstrate significant improvement in benefit-risk profile
- Should address one of four safety improvement categories:
- Reduction in known serious adverse events
- Reduction in known device failure modes
- Reduction in known use-related hazards
- Improvement in safety of another device/intervention
- Safety improvements should not compromise effectiveness
Other considerations
- Interactive and timely communication with FDA
- Review team support and senior management engagement
- Manufacturing considerations for PMA submissions
- Regular status updates with FDA
- Data Development Plan (DDP) option available
- Sprint discussions available for timely issue resolution
Relevant Guidances 🔗
- Benefit-Risk Determinations for Medical Device Premarket Review
- Q-Submission Program: Strategic Framework for FDA Interactions in Medical Device Development
- Use of Real-World Data to Generate Evidence for Medical Device Regulatory Decisions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
Related references and norms 📂
- IEC 60812: Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA)
- ISO 14971: Medical devices – Applications of risk management to medical devices
Original guidance
- Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
- HTML / PDF
- Issue date: 2021-01-06
- Last changed date: 2021-01-07
- Status: FINAL
- Official FDA topics: Medical Devices, 510(k), Premarket, Premarket Approval (PMA)
- ReguVirta ID: 0afe04546cbffeb634566e4d7f2ad442