--- title: "STeP, Safer Technologies Program | MedTech Terms" description: "FDA program for devices addressing less serious conditions but offering meaningful safety improvements. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Safer Technologies Program [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)STeP # Safer Technologies Program FDA program for devices addressing less serious conditions but offering meaningful safety improvements. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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 What is the primary goal of the Safer Technologies Program? 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. How does STeP differ from the Breakthrough Devices Program? What types of devices are typically eligible for STeP? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ 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. ](/terms/510k-summary-vs-statement)[ 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. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Mentioned in recent activity 8 entries FDA 510(k) (1)Recalls (5)PubMed (2) [HALYARD\* ONE-STEP\* Sterilization Wrap; HALYARD\* QUICK CHECK\* Sterilization Wrap; HALYARD\* SEQUENTIAL Sterilization Wrap; HALYARD\* SMART-FOLD\* Sterilization Wrap ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454) O&M Halyard, Inc. · 2026-05-18 ## Latest in MedTech [View all](/latest?term=step) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - 510(k) 2026-05-18 [HALYARD\* ONE-STEP\* Sterilization Wrap; HALYARD\* QUICK CHECK\* Sterilization Wrap; HALYARD\* SEQUENTIAL Sterilization Wrap; HALYARD\* SMART-FOLD\* Sterilization Wrap ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253454) O&M Halyard, Inc. - PubMed 2026-05-07 [A step-by-step guide for implementation of virtual surgical applications and patient data centralization: practical experience and lessons learned. ](https://pubmed.ncbi.nlm.nih.gov/42098562/) 3D printing in medicine - Recall 2026-04-02 [One Step K in vitro diagnostic test REF: 81A4 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2087-2026) Class II · DFI Co., Ltd. ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 Safer Technologies Program (STeP) Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym STeP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=step) Learn in 60 seconds Card Lesson Quiz 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. 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) ](/terms/breakthrough-device) You may also need Auto-suggested from Regulatory and shared keywords. - [Medical Device User Fee Amendments(MDUFA) ](/terms/mdufa) - [Emergency Use Authorization(EUA) ](/terms/eua) - [WHO Prequalification (Diagnostics)(WHO PQ Dx) ](/terms/who-pq-dx) - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Premarket Approval(PMA) ](/terms/pma) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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