Safer Technologies Program (STeP)
The Safer Technologies Program (STeP) is a voluntary FDA programme for medical devices that:
- Target unmet medical needs for non-life-threatening conditions; or
- Are safer alternatives to currently available treatments or diagnostics; but
- Do not meet the criteria for Breakthrough Device Designation (which requires a life-threatening or irreversibly debilitating condition)
STeP was established by FDA in 2021.
STeP vs Breakthrough Device Designation
| Feature | STeP | Breakthrough Device |
|---|---|---|
| Condition seriousness | Non-life-threatening unmet need | Life-threatening or irreversibly debilitating |
| MDUFA TTD commitment | No accelerated TTD goal | Priority review TTD |
| Enhanced FDA interaction | Yes — increased collaboration | Yes — senior staff assigned |
| Lower regulatory standard | No | No |
| FDA response to request | No formal response commitment | 60 calendar days |
Who should apply for STeP?
STeP is suitable when:
- The device addresses a non-serious unmet medical need (e.g., a safer way to perform a low-risk procedure)
- The device is likely to be materially safer than an existing alternative (e.g., reduced complications)
- The Breakthrough Device criteria are not met because the condition is not life-threatening
Benefits of STeP
- Increased FDA interaction during device development and review
- Access to FDA expertise on study design and submission requirements
- Priority scheduling for Pre-Submission meetings
- Potential for cross-CDRH programme coordination
How to apply
Submit a STeP Designation Request to CDRH:
- Describe the device and its intended use
- Explain the unmet medical need
- Describe how the device is safer than existing alternatives
- Provide available evidence of safety advantage