All terms
Safer Technologies Program
FDA program for devices addressing less serious conditions but offering meaningful safety improvements.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
STeP provides Breakthrough-style benefits - interactive review and prioritization - for devices reasonably expected to significantly improve the safety of currently available treatments or diagnostics for non-life-threatening conditions. What the regulation says
The Safer Technologies Program (STeP) was established by the FDA as a voluntary program to facilitate the development and expedite the review of certain medical devices that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics. It operates similarly to the Breakthrough Devices Program, offering manufacturers opportunities for early and frequent engagement with FDA reviewers, as outlined in FDA guidance documents on the program. Devices eligible for STeP address non-life-threatening diseases or conditions and represent a safety improvement over existing alternatives, rather than a clinical effectiveness improvement.
What this means in practice
Often used for safer redesigns of existing devices (e.g., reducing infection risk, eliminating a hazardous material). Acceptance is selective.Examples
- A novel catheter designed with an antimicrobial coating to significantly reduce the risk of hospital-acquired infections in routine, non-life-threatening procedures could be a candidate for STeP.
- A redesigned infusion pump that incorporates advanced error-prevention technology to drastically lower medication administration errors for non-critical care patients might qualify for STeP.
- A new material used in a medical implant for a non-life-threatening condition that eliminates the risk of a known biocompatibility issue present in existing materials could be considered for STeP.
Common pitfalls
- •A common pitfall is misunderstanding that STeP focuses on safety improvements for non-life-threatening conditions, not efficacy for life-threatening ones. Another mistake is assuming all safety improvements qualify, as the program specifically targets "significant" safety improvements. Manufacturers sometimes fail to provide sufficient justification that their device offers a substantial safety improvement over existing technologies when applying for STeP designation.
- •Failing to engage with the FDA early and often, which is a key benefit of the STeP program, can hinder the expedited review process.
- •Misinterpreting "non-life-threatening conditions" can lead to inappropriate applications, as the program has specific criteria for this aspect.
Frequently asked questions
The primary goal of STeP is to enhance patient safety by expediting the development and review of devices that offer significant safety improvements for non-life-threatening conditions.
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Regulatory
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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PubMed2026-05-07A step-by-step guide for implementation of virtual surgical applications and patient data centralization: practical experience and lessons learned.
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
FDA·2European Commission·1
- 1
Safer Technologies Program (STeP)VerifiedFDAfda.gov
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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