How does STeP differ from the Breakthrough Devices Program?

While both programs offer expedited review, STeP focuses on significant safety improvements for non-life-threatening conditions, whereas the Breakthrough Devices Program targets devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

What types of devices are typically eligible for STeP?

Devices eligible for STeP include those designed to reduce infection risk, eliminate hazardous materials, or minimize user error in non-life-threatening settings, representing a clear safety advantage over current options.

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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 September 19, 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. The program is aimed at devices, and device-led combination products, that fall short of the Breakthrough criteria because the condition is less serious. Participants can use sprint discussions and data development plans, and requests go in through the Q-Submission process.

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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FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.

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510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

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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.

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513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

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Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

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Category: Regulatory
Acronym: STeP
Sources: 3
Updated: 9/19/2026

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FDA program for devices addressing less serious conditions but offering meaningful safety improvements.

·Often used for safer redesigns of existing devices (e.g., reducing infection risk, eliminating a hazardous material).
·Acceptance is selective.
·The program is aimed at devices, and device-led combination products, that fall short of the Breakthrough criteria because the condition is less serious.

Remember this

Watch out: 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.

Related terms

Breakthrough Device Designation(BDD)

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