What Is FDA's STeP Program? Complete Safer Technologies Program Guide 2025

Beng Ee Lim
2 days ago
7 min read

Only 35 devices have been accepted into FDA’s Safer Technologies Program (STeP) as of early 2024, versus more than 1,040 Breakthrough Device designations. In other words, fewer than 4 % of companies are tapping this safety-focused fast track—leaving a wide-open lane for teams that can frame their innovation around risk reduction instead of headline efficacy.

Quick Answer FDA's STeP program is a voluntary fast-track pathway for medical devices that significantly improve safety of existing treatments without targeting life-threatening conditions. Unlike Breakthrough Devices, STeP focuses on safety innovations rather than efficacy improvements, offering prioritized review, enhanced FDA communication, and investor credibility for devices treating less serious conditions.

This guide reveals how forward-thinking companies are leveraging STeP to cut review times, access senior FDA management, and differentiate themselves in competitive markets.

URGENT: If Your Device Could Qualify for STeP

CHECK THESE REQUIREMENTS IMMEDIATELY:

Safety Innovation: Does your device reduce known serious adverse events, device failures, or use errors?
Regulatory Pathway: Subject to PMA, 510(k), or De Novo review?
Non-Life-Threatening Focus: Treats conditions less serious than Breakthrough criteria?
Not Already Submitted: Haven't filed your marketing application yet?

If you answered yes to all four, you could be missing a major competitive advantage that 90% of your competitors don't even know exists.

What Is FDA's STeP Program?

The Safer Technologies Program (STeP) is FDA's voluntary program for medical devices and device-led combination products that significantly improve the safety of existing treatments or diagnostics. The program aims to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for regulatory pathways.

Here's what makes STeP strategically brilliant: It's designed for devices that improve safety rather than efficacy, filling a crucial gap that Breakthrough Devices Program doesn't address.

STeP vs. Breakthrough: The Critical Difference

Breakthrough Devices: Focus on more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases

STeP Devices: Target underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program, including devices treating or diagnosing non-life-threatening or reasonably reversible conditions

This distinction creates enormous opportunity for devices that enhance safety without necessarily revolutionizing efficacy.

The Numbers Tell the Story

Current STeP Statistics:

Currently 35 devices included in the STeP program
In 2023, 15 STeP devices were enrolled and two were authorized for marketing

Compare to Breakthrough:

By the end of 2023 the FDA had granted about 1,000 Breakthrough Device designations (more than 1,040 by September 2024)
over 80 devices subsequently received marketing authorization by CDRH

The massive disparity reveals an underutilized pathway with far less competition.

Why Smart Companies Are Choosing STeP Over Breakthrough

Real Success Stories Breaking in 2025

RevMedica Endo Stapling Platform: RevMedica announced that the FDA accepted its Endo stapling platform into its Safer Technologies Program (STeP) in January 2025. The company focuses on revolutionizing soft tissue management while optimizing clinical decision-making and elevating patient safety.

Medtronic Nellcor Technology: Medtronic announced in May 2025 that the FDA accepted its new Nellcor pulse oximetry technology into its STeP program. The investigative Nellcor technology aims to integrate patient-specific and sensor-specific data into oxygen saturation calculations used in pulse oximetry.

Strategic Advantages Over Breakthrough

Lower Competition: With only 35 devices in STeP vs about 1040 in Breakthrough, your application faces significantly less competition for FDA attention and resources.

Investor Appeal: A Breakthrough or STeP device designation gives investors added confidence in a company, and if the FDA has recognized your product as one that will advance public health and/or offer superior treatment, investors are more likely to take a chance on your organization.

Realistic Qualification: Many safety-focused innovations that can't meet Breakthrough's life-threatening criteria can easily qualify for STeP.

STeP Eligibility: The Two-Factor Test

To qualify for STeP, your device must meet both eligibility factors:

Factor 1: Exclusion from Breakthrough

Not eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device.

Translation: Your device doesn't treat life-threatening conditions, but that's actually perfect for STeP.

Factor 2: Significant Safety Improvement

Your device should provide substantial safety innovations that achieve one or more of the following:

Reduction in Serious Adverse Events: A reduction in the occurrence of a known serious adverse event
Device Failure Prevention: A reduction in the occurrence of a known device failure mode
Use Error Mitigation: A reduction in the occurrence of a known use-related hazard or use error
Safety Enhancement: An improvement in the safety of another device or intervention

The STeP Benefits That Transform Your Business

Accelerated FDA Interaction

Sprint Discussions: Sprint discussions to facilitate timely resolution of clinical or non-clinical evaluation issues (within 45 days) compared to traditional 75-day pre-submissions.

Senior Management Access: Manufacturers can also expect interactive and timely communications, early engagement on Data Development Plans, sprint discussions, and senior management engagement to support the program, as resources permit.

Enhanced Review Support: Increased review team support (e.g., including senior management to support efficient dispute resolution) and additional resources to review regulatory submissions.

Business Development Advantages

Investor Confidence: STeP designation signals FDA validation of your safety innovation approach, making fundraising conversations significantly easier.
Competitive Differentiation: While competitors struggle with standard review timelines, you're fast-tracking to market with FDA's stamp of approval.
Market Positioning: STeP designation positions your company as a safety leader, crucial for healthcare purchasing decisions.

How to Apply for STeP: Step-by-Step Strategy

Application Process

Sponsors interested in participating in STeP as part of their device development should submit a Q-Submission requesting inclusion in STeP with this request highlighted in the cover letter. This request should be the only request in the Q-Submission.

Required Information

The FDA recommends that your request include information to describe the device, the proposed indications for use, expected safety improvement, regulatory history, how your device meets the STeP objectives, and what type of marketing submission you plan to submit to the FDA for your device.

Timeline Expectations

Acknowledgement: FDA typically confirms receipt of your Q-Submission within ~14 days.

Final Determination: The agency intends to issue its decision on STeP inclusion within 60 calendar days of a complete request.

Strategic Timing

To receive the most benefit from program participation, ideally a request seeking inclusion for a device in STeP will be sent prior to sending your marketing submission.

Best Practice: Apply during early development phases to maximize FDA interaction benefits throughout your development process.

STeP Features That Accelerate Development

Data Development Plan (DDP) Review

Review of a data development plan (an optional, high-level document outlining data collection expectations, including non-clinical testing approaches and/or clinical evaluation strategies, for the entire device lifecycle).

Strategic Value: Get FDA agreement on your entire data collection strategy before investing in expensive studies.

Flexible Study Design

Consideration of proposals for efficient and flexible clinical study design allows for innovative approaches that traditional pathways might reject.

Post-Market Advantages

Timely post-market data collection for PMAs and De Novo requests streamlines ongoing obligations and market maintenance.

Common STeP Qualification Mistakes to Avoid

Mistake 1: Confusing Safety with Efficacy

Many companies think improved outcomes automatically qualify for STeP. Remember: STeP focuses specifically on safety innovations, not just better clinical results.

Mistake 2: Applying Too Late

STeP is very new and not all FDA divisions have experience with this program; therefore, the process may initially be more burdensome. Apply early to work through any procedural issues with FDA.

Mistake 3: Inadequate Safety Documentation

FDA intends to review the principles of operation of the device and preliminary data from non-clinical or clinical studies to assess the improvement in overall benefit-risk. Prepare robust safety data before applying.

Mistake 4: Generic Applications

A key requirement for a device to be eligible for the STeP designation is to incorporate an innovative technology feature, not simply improved labeling (Instructions for Use), to enable a substantial safety improvement.

STeP Success Stories: What FDA Actually Approves

Medical Device Categories Succeeding in STeP

Surgical Platforms: RevMedica's stapling technology demonstrates how surgical safety innovations qualify for expedited review.

Diagnostic Improvements: Medtronic's pulse oximetry advances show how sensor accuracy enhancements meet STeP criteria.

Innovation Types That Qualify

Examples of such innovations may include simpler, more robust designs, better materials, better software, simpler user-interface and error-proof operation.

Real-World Applications:

Devices reducing surgical complications
Technologies preventing user errors
Systems improving diagnostic accuracy
Platforms minimizing device failures

Don't Let Your Competition Discover STeP First

With only 35 devices in STeP compared to 1000s in Breakthrough Devices, the opportunity window won't stay open forever. Smart companies are already leveraging this hidden pathway to accelerate their regulatory timelines while their competitors remain unaware.

The Bottom Line: While your competitors chase the crowded Breakthrough pathway, you could be fast-tracking safety innovations through STeP's expedited review process.

Get Expert STeP Strategy Guidance: Complizen helps medtech companies identify and leverage underutilized FDA pathways like STeP.

Frequently Asked Questions

Can I apply for both STeP and Breakthrough Devices?

No. The way FDA set these two programs up, they are mutually exclusive. If you get a BDP, you cannot get a STeP. Choose the pathway that best matches your device's value proposition.

Does STeP reduce regulatory requirements?

No. Inclusion in the program does not mean a device is "safe" or "safer," the final guidance emphasizes. Rather, acceptance into the program only means there is a "reasonable expectation" that a device may significantly improve on the current risk-benefit profile.

How long does STeP application review take?

Based on the 30-day review from FDA, a manufacturer will gain a clearer understanding regarding the viability of their request with final determination within 60 days.

What happens if my STeP application is rejected?

A manufacturer can choose to withdraw from the program at any time, including after the initial 30-day review. You can then proceed with traditional regulatory pathways.

How many devices typically get STeP approval?

The acceptance rate appears favorable given the low volume of applications. With only 35 devices in the program and 15 enrolled in 2023 alone, FDA seems receptive to qualified applications.

Does STeP help with reimbursement?

While not explicitly stated, STeP designation demonstrates FDA recognition of your device's safety value, which can strengthen reimbursement discussions with payers focused on patient safety outcomes.

Can international companies apply for STeP?

Yes, any company seeking FDA marketing authorization for qualifying devices can apply for STeP, regardless of company location.

What if my device improves both safety and efficacy?

What if you have devices that include both safety and efficacy improvements? You'll need to choose which pathway better represents your primary value proposition, as the programs are mutually exclusive.